arr _arun product final pdf-000200144229
DESCRIPTION
SSTRANSCRIPT
ANNUAL REVIEW REPORT- PRODUCT
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1Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ANNUAL REVIEW REPORT OF
LIP-3 (OLANZAPINE
CANADIAN MKT)
ANNUAL REVIEW REPORT- PRODUCT
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2Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
DOCUMENT APPROVAL SHEET
Department Name and Designation Signature
Compiled By:
External Consultants HP - Adinarayana Reddy Chennepalli Consultant
P90003214 06.10.2015 11:29:28
Reviewed By:
External Consultants HP - Adinarayana Reddy Chennepalli Consultant
P90003214 06.10.2015 11:53:52
Approved By:
External Consultants HP - Adinarayana Reddy Chennepalli Consultant
P90003214 06.10.2015 12:19:43
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
TABLE OF CONTENTS
S.NO. CONTENT PAGE NO.
1.0 PRODUCT DESCRIPTION 4
2.0 BATCH PRODUCTION AND DISPATCH DETAILS 5
3.0REVIEW OF STARTING MATERIALS & PACKAGING MATERIALS FROM NEW SOURCE 6
4.0 REVIEW OF BIO-BURDEN ON PRODUCT 8
5.0 REVIEW OF OOS & OOT RESULTS 9
6.0 REVIEW OF REPROCESS & REWORK 11
7.0 REVIEW OF INCIDENTS 12
8.0 REVIEW OF CHANGE CONTROLS 19
9.0 REVIEW OF STABILITY MONITORING PROGRAM 28
10.0 REVIEW OF CUSTOMER COMPLAINTS,RETURNED GOODS & RECALLS 31
11.0 REVIEW OF VALIDATION ACTIVITIES 34
12.0 REVIEW OF REGULATORY FILING STATUS 36
13.0 REVIEW OF RETAINED SAMPLES(FINISHED PRODUCT) 37
14.0 REVIEW OF QUALITY TRENDS OF API STARTING MATERIAL 38
15.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF INTERMEDIATE STAGE(S) OF PRODUCT
39
16.0 REVIEW OF QUALITY TRENDS OF INTERMEDIATE STAGE(S) OF PRODUCT
40
17.0 REVIEW OF YIELD TRENDS OF INTERMEDIATE STAGE OF PRODUCT 41
18.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF FINISHED STAGE(S) OF PRODUCT
42
19.0 REVIEW OF QUALITY TRENDS OF API (FINISHED) STAGE OF PRODUCT 43
20.0 REVIEW OF YIELD TRENDS OF API (FINISHED) STAGE OF PRODUCT 148
21.0 REVIEW OF LAST ARR 151
22.0 SUMMARY REPORT 152
23.0 CONCLUSION AND RECOMMENDATIONS 172
ANNEXURE - III
ANNEXURE - II
ANNEXURE - I
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
1.0 PRODUCT DESCRIPTION :
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
Type of Product: API
SAP Code: 200001445
Chemical Name: Sample for testing
Codes of Manufacturing Stages:
Intermediate Product Code Description
200001445 LIP-3 (OLANZAPINE CANADIAN MKT)
Key Starting Material Code Description
200004950 LIP-3 (OLANZAPINE CANADIAN MKT)
API Description
200001445 LIP-3 (OLANZAPINE CANADIAN MKT)
200004950 LIP-3 (OLANZAPINE CANADIAN MKT)
200004950 LIP-3 (OLANZAPINE CANADIAN MKT)
ANNUAL REVIEW REPORT- PRODUCT
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5Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
2.0 BATCH PRODUCTION AND DISPATCH DETAILS:
2.1 Summary of Production of Intermediates and API batches:
Product Stage(Intermediate/
API)
Product Stage Code
No. Of Batches Manufactured
Quantity Manufactured UOM Material Type
200001445(API) LIP-3 (OLANZA 00001 9.100 KGМер.графік з
контирув.операцій (вн.нум.)
200001445(API) LIP-3 (OLANZA 00152 1366.300 KGNormal Production
Process
200001445(API) LIP-3 (OLANZA 00026 230.400 KG Packing order
200001445(API) LIP-3 (OLANZA 00001 8.600 KG Process Order - Recovery (2nd Corp)
200001445(API) LIP-3 (OLANZA 00005 32.400 KG Reprocess order
2.2 Dispatch Details of Product:(Market)
S.No Market Name Qty. (in Kg)
NA NA NA
Total 0.000
2.3 Dispatch Details of Product(FTO):
S.No Plant Qty. (in Kg)
1 6052 915.500
Total 915.500
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
3.0 REVIEW OF STARTING MATERIALS & PACKAGING MATERIALS FROM NEW SOURCE:
3.1 Raw Materials:
S.No Material Name/Code Source Details Status of vendor
Date of Approval Remarks
NA NA NA NA NA NA
QA Final Comments
Reviewed Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:07:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 15:59:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35
3.2 Packaging Materials:
S.No Material Name/Code Source Details Status of vendor
Date of Approval Remarks
1 APPROVED VENDOR()SAMPLE FOR
TESTINGAPPROVED
VENDOR16-10-2014 NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
QA Final Comments
Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:07:54 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 15:59:23 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35
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8Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
4.0 REVIEW OF BIO BURDEN ON PRODUCT:
200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of
Specification Ref. No.
S.No. Batch No.
QA FINAL COMMENTS:
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
5.0 REVIEW OF OOS & OOT RESULTS:
5.1 Summary of OOS Results:
S.No Product Stage Code
OOS Notification
No.
Date of Reporting Batch No. Description of
OOSInvestigation Status
Batch Status
1 16-10-2015 ADIH000198
Inspection Spec
Accepted
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52
5.2 Summary of OOT Results:
S.No.
Product Stage Code
OOT Notification
No.
Date of Reporting Batch No. Description of OOT Investigati
on StatusBatch Status
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 sss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
6.0 REVIEW OF REPROCESS & REWORK:6.1 Summary of Reprocessing & Reworking of Intermediates and API Batches:
Material Code Material In-house Stage Code
No. of Batches Reprocessed
Quantity Produced by Reprocess (Kg)
No. of Batches Reworked
Quantity Produced by Rework (Kg)
200001445 LIP-3 1 6.200 0 NA
200001445 LIP-3 1 5.200 0 NA
200001445 LIP-3 1 8.600 0 NA
200001445 LIP-3 1 6.300 0 NA
200001445 LIP-3 1 6.100 0 NA
QA Final Comments
Reprocessed batch nos. that failed meeting specification: 0 ,ADIH001371 Reworked batch nos. that failed meeting specification: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:58 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:58 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:20:39 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:40 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:47 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:54:27
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
7.0 REVIEW OF INCIDENTS:
7.1 Summary of Incidents:
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
1 NA 200109073 17-10-2014
0 While processing the RS/HPLC chromatogram of Olanzapine F-1 bearing B.No.ADHH001302, the baseline of the sample found not good.
CLOSED NA
2 NA 200110553 13-11-2014
LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003499 Obtained additional peaks in XRD test. Result : Sample XRD pattern does not matches with standard. Specification: To match with working standard. OOS number: OOS07014
CLOSED NA
3 NA 200110554 13-11-2014
LIP-3 Stage of Olanzapine (Form-1) having batch number ADHH003500 Additional peaks are observed. Result : Sample pattern does not matches with standard. Specification: To match with working standard. OOS Number : OOS07114
CLOSED NA
4 NA 200112085 14-11-2014
LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003527 Additional peaks observed in XRD test. Result : Does not matches with working standard. Specification: To match with working standard. OOS Number : OOS07214
CLOSED NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
5 NA 200112270 17-11-2014
LIP-3 Stage of Olanzapine (Form-1) having Batch number ADHH003527 In Related substances by HPLC, the Total impurities after summing Method-1+ Method-2 is observed as OOT. Result: Total impurities (Method-1 + Method-2) = 0.17% Specification: Not more than 0.2% OOT number: OOT05514
CLOSED NA
6 NA 200114407 08-12-2014
As per EP analysis: 1. LIP-3 stage of Olanzapine Form-1 (Canada) batch number ADGH002297 was found to be out of control limit with respect to Total impurities, result is 0.19% against the control limit of 0.06-0.18%. 2. LIP-3 stage of Olanzapine Form-1 (Canada) batch number ADGH002189 was found to be out of control limit with respect to Methylene Di chloride content, result is 321ppm against the control limit of87-263ppm. As per In house analysis: 1. LIP-3 stage of Olanzapine Form-1 (Canada) batch numbers ADHH001184 and ADHH001330 were found to be out of control limit with respect to Methylene Dichloride content, results are 241ppm and 463ppm respectively= <(>,<)> against the control limit of 87-263ppm.
CLOSED NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
7 NA 200116035 21-12-2014 For LIP-3 bearing Batch No.ADHH003940 Water content by KF result obtained as 0.00%.
CLOSED NA
8 NA 200117161 31-12-2014
In LIP-3 stage of Olanzapine (Form-1) having B.NO:ADEH003449 initiated for stability study. During long term stability study at 36 months found OOS in related substance by HPLC in any other Impurity and Total impurities as per in house specification. Details are: Result: Any other impurity: 0.23% and Total Impurities: 0.66% Specification: Any other impurity: Not more than 0.10% and Total Impurities: 0.50%
NA
9 ADEH003449
200117336 03-01-2015
The Out of specification was observed in Olanzapine F-1 (Canada) stability batch with No. ADEH003449 LT 36M in Related substances by HPLC as per In house Spec and MOA.
CLOSED NA
10 NA 200117528 06-01-2015
LIP-3 stage of Olanzapine (Form-1) having Batch No: ADIH000038 at op No: 54(drying operation) in-process water content (Sample No.LIP-3-02) result obtained as 0.8% W/W against the Limit 0.5% W/W
CLOSED NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
11 ADGH001516
200118309 13-01-2015
The "Out of specification" in Related substances by HPLC - "Any Other Impurity" impurities and “Out of trend” for Total impurities as per Spec and MOA S-08-OI-USP/01 was found .The Out of specification in Related substances by HPLC for Unspecified and Total impurities as per S-08-OI-Ph.Eur/01 was found.
CLOSED NA
12 NA 200124845 09-03-2015
In LIP-3 stage of Olanzapine (Form-1) Canada having Batch Number ADIH000580, unspecified impurity in related substance by HPLC (Method-1) and Total impurities in related substance by HPLC (Method-1+Method-2) as per Ph. Eur results obtained as OOT. Unspecified impurity result: 0.10% Specification: NMT 0.10% Total impurities result: 0.24% Specification: NMT 0.2% OOT NO: OOT 02015
CLOSED NA
13 NA 200126960 26-03-2015
LIP-3 Stage of Olanzapine (Form-1) having Batch number ADIH000874 multiple strike off's observed at operation number 52 at page 40 of 45
CLOSED NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
14 NA 200128463 09-04-2015
LIP-3 stage of Olanzapine (Form-1) having Batch No: ADIH000989 at op No: 54(drying operation) in-process water content (Sample No.LIP-3-02) result obtained as 0.6% W/W against the Limit 0.5% W/W
CLOSED NA
15 NA 200129582 17-04-2015
LIP-3 stage of Olanzapine (Form-1) Batch No. ADIH000988 water content result obtained as out of trend. Result: 0.41%W/W Specification: Not more than 0.5%W/W OOT No.: OOT 03415
CLOSED NA
16 NA 200129583 17-04-2015
LIP-3 stage of Olanzapine (Form-1) Batch No. ADIH000989 water content result obtained as Out of trend. Result: 0.50%W/W Specification: 0.5%W/W OOT No. : OOT 03515
CLOSED NA
17 NA 200133147 19-05-2015
LIP-3 Stage of Olanzapine (Form-1)having Batch number ADIH001270 In related substance by HPLC LIP-2 Quaternary salt impurity result obtained as OOT. Specification: LIP-2 Quaternary salt not more than 0.15% Result : 0.14% OOT number : OOT05215
CLOSED NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.NO Batch No. Incident No. Date of Reporting Description of Incident
Status of Incident
Investigation
Root Cause (if Identified)
18 NA 200133352 20-05-2015
Lip-3 stage of Olanzapine (Form-1) having Batch NO: ADIH001372 water content result as out of trend as per in house method. Result: 0.5% W/W Specification: NMT 0.5% W/W OOT NO: OOT 05315
CLOSED NA
19 NA 200135307 07-06-2015
In LIP-3 stage of Olanzapine (Form-1) Canada having Batch Number ADIH001419 Total impurities result obtained as Out of trend as per Ph.Eur. Result: 0.20% Specification: NMT 0.2% OOT No. OOT06015
CLOSED NA
20 ADIH001583 200136601 17-06-2015
In LIP-3 stage of Olanzapine (Form-1), during sample collection of ADIH001583 batch (dated on 17.06.2015 at 9:20 hrs), wetness was observed on the inner surface of the black polybag which is one of the three layers of packing material used for product packing. Hence the sample was not collected by the analyst.
CLOSED NA
21 ADIH001583 200144255 16-10-2015
In LIP-3 stage of Olanzapine (Form-1), during sample collection of ADIH001583 batch (dated on 17.06.2015 at 9:20 hrs), wetness was observed on the inner surface of the black polybag which is one of the three layers of packing material used for product packing. Hence the sample was not collected by the analyst.
CLOSED NA
QA Final Comments
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18Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Total no. of incidents reported during this review period: 20 No. of incidents closed: 19 No. of incidenets open: 0 No. of incidents of previous rev period closed in this rev period: 0 No. of incidents of previous rev period still open in this rev period: 0 Total no. of CAPAs raised during the review period: 0 No. of CAPAs closed: 0 No. of CAPAs open: 0 No. of CAPAs that crossed timeline, but closed: 0 No. of overdue open CAPAs: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:28:08 great Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:28:08 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:21:25 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:02:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:55:07
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
8.0 REVIEW OF CHANGE CONTROLS:
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
1 21-10-2014200109569 Permanent Change
Product and
Process/Permanent Change
To assign the shelf life for Olanzapine F-1 (Canada) as per USP as 24 months.
Minor OPEN
2 01-12-2014200113672 Temporary Change
Material/Material
Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches.
Minor OPEN
3 30-12-2014200116897 Permanent Change
Document/Batch
production record
I.,,Proposed to obsolete the LIP-3 stage batch production records with the form no.s F-10-729/00 (Wet BPR) & MF.No.: MF-LIP-3-007/00 and F-10-730/00 (Dry BPR) & MF.No.: MF-LIP-3-007/00 II.,,Proposed to obsolete the LIP-3R stage batch production records with the form no.s F-10-731/00 (Wet BPR) & MF.No.: MF No.: MF-LIP-3R-019/00 and F-10-732/00(Dry BPR) & MF No.: MF-LIP-3R-019/00
Minor OPEN
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
4 29-01-2015200120274 Permanent Change
Document/Change in formats
1) The Olanzapine F-1 (Canada) shall be assigned shelf life of 24 months Expiry as per In house, USP and Ph.Eur and the same shall be mentioned in templates of Spec and MOA’s. (List enclosed) 2)Proposed to remove the 36th,48th and 60th month stability samples of Olanzapine F-1 (Canada) from the chamber and conduct the stability study till 24 months based on the shelf life assigned i.e, 24 Months expiry Period and accordingly to revise the stability data sheets. F-20-347/06, F-20-557/02, F-20-714/01, for In-House, USP and Ph.Eur sub sequentially. List of batches with intervals to be removed is enclosed
Minor OPEN
5 28-02-2015200123883 Permanent Change
Material and
Process/Change Control
issu
The Olanzapine F-1 Canada shall be assigned expiry period 18 months as per In house, USP and Ph.Eur and the same shall be mentioned in templates of Spec and MOA’s. Major CLOSED
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
6 19-03-2015200126162 Permanent Change
Document/Batch
production record
I. LIP-3 scale-up: Proposed to revise LIP-3 scale-up BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3 stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-781/09 & MF-LIP-3-008/01. II. LIP-3 scale down: Proposed to revise LIP-3 scale down BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3 stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-245/15 & MF-LIP-3-005/05 III. LIP-3R: Proposed to revise LIP-3R BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3R stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13 . Proposed document No.: F-10-404/10 & MF-LIP-3R-017/02 IV. LIP-3RD: Proposed to revise LIP-3RD BPR with the following changes. 1. Proposed to use Sifter (2500937) in LIP-3RD stage. 2. Proposed to change BPR format as per the SOP current version of 01-018/13. Proposed document No.: F-10-799/02
Minor OPEN
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
7 23-03-2015200126529 Permanent Change
Product/Product
Proposed to revise in process and intermediate water content limit LIP-2/LIP-22/LIP-2RC/LIP-2R stage as NMT 8.0% w/w
Minor CLOSED
8 02-04-2015200127822 Permanent Change
Document/STP/MOA
1) S-09-LIP3-01/06 2) Propose to revise LIP-3 Rinsed / Swab sample spec & MOA with specification limit is NMT: 1.96 ppm
Minor OPEN
9 09-04-2015200128544 Permanent Change
Document/STP/MOA
1) S-08-OI-Ph.Eur/02& CS-OI-003/10 ( Actavis EDMF spec & MOA) 2) Propose to revise Olanzapine form-1 Canada Ph.Eur & Actavis customer spec & MOA's with test sample weight is 2 g in Heavy Metals Method of analysis.
Minor CLOSED
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
10 17-04-2015200129511 Permanent Change
Document/STP/MOA
1.1) Revise Spec No : S-08-OI/14 in-house 1.2)Propose to revise Olanzaine form-1 in-house spec & MOA with Moisture Content method of analysis media is Methanol and test sample is about 1.0 g. 1.3)S-08-OI-Ph.Eur/02 1.4) Propose to revise Olanzaine form-1 Ph.Eur spec & MOA with Water Content method of analysis media is Methanol and test sample is about 1.0 g. 1.5)ROA's are revised with current versions : 200001445-V09 , 200001445-Ph.Eur-V04<(>,<)> 200001445-STAB-EP-V03 & 200001445-STAB-IH-V03
Minor CLOSED
11 13-05-2015200132434 Temporary Change
Equipment and
Process/Process
Proposed to take trials using Hyflo modular filter. The trial material samples will be analyzed in QC.
Minor OPEN
12 22-05-2015200133570 Permanent Change
Equipment and
Facility/Equipme
nt and Fac
,,In this system primary condenser will be installed horizontally and 100% area will be utilized. Secondary condenser will be installed inside the plant with balancing line and completely smell of DMSO will be reduced.
Minor CLOSED
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
13 28-05-2015200134220 Permanent Change
Document/STP/MOA
Propose to revise the water by KF method with media as Acetic acid and Methanol (5:50) for Olanzapine form-1 (Canada) Finished (In-house) and in process spec & MOA. Proposed Specification No.s: Finished: S-08-OI/14 In process: S-02-LIP-3-02/04 To revise ROA of Finished product with current version No : 200001445-V09
Minor CLOSED
14 18-06-2015200136734 Permanent Change
Document/STP/MOA
Proposed to harmonize Olanzapine (Form-1) (LIP-3) HPLC method of analysis (Related substances and Assay by HPLC) by adopting USP MOA Propose to include additional method of analysis (Other pharmacopeias & In-house methods) as alternative for chemical analysis in all Spec. & MOAs. Method details and List of specification which shall be revised. Annexure are enclosed.
To be identified OPEN
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
8.1 Summary of Approved Change Controls:
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
15 07-07-2015200138999 Permanent Change
Document/Batch
production record
Proposed to regularize the validated changes of LIP-2 scale up for 85.00 (±5.00) Kg input batch size of LIP-1/LIP-1R by regularizing the BPR. Major process changes are as follows. i) Acetic acid Lot-1 Qty. is used as 7.0 L (6.6-7.4 L) instead of 3.4 L (3.2-3.6 L) for 1st Re-crystallization process. ii) Acetic acid Lot-2 Qty. is used as 11.5 L (10.8-12.2 L) instead of 7.8 L (7.3-8.3 L) for 2nd Re-crystallization process. iii) Dimethyl sulfoxide Lot-4 Qty. is used as 194.0 L (183.0-205.0 L) instead of 170.0 L (160.0-180.0 L) for 2nd Re-crystallization process. iv) DM water II Lot-7 Qty. is used as 50.0 L (47.0-53.0 L) instead of 44.0 L (41.0-46.0 L) for 2nd Re-crystallization process. v) Dimethyl sulfoxide Lot-6 Qty. is used as 158.0 L (149.0-167.0 L) instead of 134.0 L (126.0-141.0 L) for 3rd Re-crystallization process vi) Dimethyl sulfoxide Lot-7 Qty. is used as 180.0 L (i.e; 6 times to the third RC wet weight qty. of 30 Kg) instead of 135.0 L (i.e 4.5 times of the 3rd RC wet quantity of 30 Kg) for 4th Re-crystallization process vii) DM water II Lot-11 Qty. is used as 45.0 L (i.e; 1.5 times to the third RC wet weight qty. of 30 Kg) instead of 30.0 L (i.e; 1 time of the 3rd RC wet quantity of 30 Kg) for 4th Re-crystallization process viii) DM water II Lot-12 Qty. is used as 121.0 L (114.0-128.0 L) for washing of wet cake instead of 60.0 L (i.e; 2 times of the 3rd RC wet quantity of 30 Kg) during centrifugation in 4th Re-crystallization process Operational changes are captured in the change annexure and is attached to the document link. Proposed document No.: F-10-765/13 & MF-LIP-2-009/01
Minor CLOSED
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No
Date of Initiation
Notification No.
Type of change
(Temporary/
Permanent)
Change Required
InDescription of Change
Category of Change
(Major/Minor)
Current status of Closure
16 08-07-2015200139158 Temporary Change
Material/Material
Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches. To be
identified OPEN
17 16-10-2015200144255 Temporary Change
MATERIAL/
MATERIAL
Proposed to deviate FIFO and use PIN-3P from M/s.Kopalle Pharma Chemicals Pvt. Ltd. in LIP-1 stage for ~ 20 batches. To be
identified OPEN
QA Final Comments
Total no. of change control inititated: 16 No. of change control closed: 7 No. of change control open: 9 No. of change control of previous rev. period closed in this 0 No. of change control of previous rev. period still open at 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:29:11 good Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:29:11 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:23:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On
ANNUAL REVIEW REPORT- PRODUCT
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27Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
:06/10/2015 at 11:10:59 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:03:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:56:32
ANNUAL REVIEW REPORT- PRODUCT
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28Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
9.0 REVIEW OF STABILITY MONITORING PROGRAM:
9.1 Accelerated Stability Studies:
Temperature/RH :
Packaging Condition:
S.No. Batches kept for Study Reason for Study Date of Samples
kept for StudyLast station
Analyzed Observations
NA NA NA NA NA NA
QA Final Comments
Reviewed Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
ANNUAL REVIEW REPORT- PRODUCT
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29Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
9.2 Long Term Stability Studies:
Temperature/RH :
Packaging Condition:
S.No. Batches kept for Study Reason for Study Date of Samples
kept for StudyLast station
Analyzed Observations
NA NA NA NA NA NA
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:42:14 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:42:14 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
9.3 Intermediate Stability Studies:
Temperature/RH :
Packaging Condition:
S.No. Batches kept for Study Reason for Study Date of Samples
kept for StudyLast station
Analyzed Observations
NA NA NA NA NA NA
QA Final Comments
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On
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30Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
:05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
10.0 REVIEW OF CUSTOMER COMPLAINTS,RETURNED GOODS & RECALLS:
10.1 Summary of Customer Complaints:
S.No Date of Reciept
Customer Name
Complaint No. Batch No. Description of
Complaint
Date of Complaint
ClosureConclusion
NA NA NA NA NA NA NA NA
QA Final Comments
Total no. of complains received during this review period:NIL No. of complaint investigation closed:NIL No. of investigation open:NIL No. of complaints of previous review period closed in this review period: 0 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32
10.2 Summary of Returned Goods:
S.No Date of Receipt
Customer Name Report No. Batch No. Reason for
Return
Action Proposed/
Taken
Current status of Closure
NA NA NA NA NA NA NA NA
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
QA Final Comments
No. of returns goods notification received during this review period:NIL No. of return goods notification closed:NIL No. of return goods notification open:NIL No. of batches returned during this review period:NIL Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32
10.3 Summary of Recalls:
S.No. Date of Initiation
Customer Name Report No. Batch No. Reason for
RecallAction
Proposed/Take nCurrent Status
of Closure
1 16.10.2015Sample
customer for testing
1234 ADIH000198
RECALL-SAMPLE
FOR TESTING
NA NA
QA Final Comments
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On
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33Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
:06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
11.0 REVIEW OF PROCESS VALIDATION ACTIVITIES:
11.1 Summary of Process Validation:
S.No.Date of
Protocol Approval
Validation Protocol No.
Type of Validation
Reason for Validation
Validation Batch No.(s)
Current Status of
Study
NA NA NA NA NA NA NA
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38
11.2 Summary of Cleaning validation:
S.No. Date of Approval Protocol
Validation Protocol No. Reason for Validation Validation Batch No.
(s)Current Status of
Study
NA NA NA NA NA NA
QA Final Comments
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
12.0 REVIEW OF REGULATORY FILING STATUS:
12.1 Summary on Regulatory Filing:
S.No Date of Filing Name of Regulatory Filing Type of Filing Currrent Status of File
1 10, 2015 Sample for testing Updation Active
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:45:28 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:45:28 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:47 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:56 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:30 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:30:52 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:59:27
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
13.0 REVIEW OF RESERVE SAMPLES (FINISHED PRODUCT):
S.No. Batch No. Date of
ManufacturingDate of
Observation Description Sample pack Integrity Remarks
NA NA NA NA NA NA NA
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:46:19 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:46:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:28:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:28:48 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:15:08 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:31:33 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:00:28
ANNUAL REVIEW REPORT- PRODUCT
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38Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
14.0 REVIEW OF QUALITY TRENDS OF API STARTING MATERIAL:
Quality Trend of
Specification Ref. No.
S.No. Batch No.
QA FINAL COMMENTS
ANNUAL REVIEW REPORT- PRODUCT
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CTO UNIT-IV
39Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
15.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF INTERMEDIATE STAGES(S) OF PRODUCT:
Product Stage Code :
BPR Ref.No.
S.No Batch No. Incident No. Date of Incident
Description of the Incident
Status of Incident Investigation Batch Status
NA NA NA NA NA NA NA
QA Final Comments
ANNUAL REVIEW REPORT- PRODUCT
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40Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
16.0 REVIEW OF QUALITY TRENDS OF INTERMEDIATE STAGES(S) OF PRODUCT:
Quality Trend of
Specification Ref. No.
Scale
Validation Form No.
S.No. Batch No.
QA FINAL COMMENTS
ANNUAL REVIEW REPORT- PRODUCT
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41Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
17.0 REVIEW OF YIELD TRENDS OF INTERMEDIATE STAGES OF PRODUCT:
Product Stage Code
BPR Ref.No. (Current Version):
S.No. Batch No.
Yield Results
Average
Standard Deviation
+3 Sigma limit
-3 Sigma limit
Details of Yield deviation batches:
S.No. Batch No. Incident No. Date of Incident Description of the Incident
Status of the Incident Investigation Batch Status
NA NA NA NA NA NA NA
QA Final Comments:
ANNUAL REVIEW REPORT- PRODUCT
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42Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
18.0 REVIEW OF CRITICAL PROCESS PARAMETERS OF FINISHED STAGES(S) OF PRODUCT:
200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of
BPR Ref.No.
S.No Batch No. Incident No. Date of Incident
Description of the Incident
Status of Incident Investigation Batch Status
NA NA NA NA NA NA NA
QA Final Comments
ANNUAL REVIEW REPORT- PRODUCT
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43Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
19.0 REVIEW OF QUALITY TRENDS OF FINISHED STAGES(S) OF PRODUCT:
19.1.1 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of
S-08-OI-Ph.Eur/01Specification Ref. No.
20.00Scale
NOT APPLICABLEValidation Form No.
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
1 ADHH003195Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
192.0 100.5
2 ADHH003163Yellow,
crystalline powder.
Complies Complies
0.01 0.3 Less than 10 ppm
191.7 99.9
3 ADHH003162Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
192.1 99.2
4 ADHH003914Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
192.6 100.2
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
44Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
5 ADHH003860Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
193.7 100.3
6 ADHH003859Yellow,
crystalline powder.
Complies Complies
0.01 0.5 Less than 10 ppm
192.4 100.9
7 ADHH003857Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
192.5 100.5
8 ADHH003856Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.2 100.2
9 ADHH003855Yellow,
crystalline powder.
Complies Complies
0.02 0.4 Less than 10 ppm
192.5 100.2
10 ADHH003849Yellow,
crystalline powder.
Complies Complies
0.02 0.3 Less than 10 ppm
193.1 99.9
11 ADHH003697Yellow,
crystalline powder.
Complies Complies
0.02 0.08 Less than 10 ppm
192.2 99.4
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
45Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
12 ADHH003696Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.9 99.4
13 ADHH003668Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.1 99.8
14 ADHH003638Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
192.1 100.1
15 ADHH003637Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.2 99.5
16 ADHH003615Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.4 99.4
17 ADHH003612Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.2 99.3
18 ADHH003587Yellow,
crystalline powder.
Complies Complies
0.03 0.05 Less than 10 ppm
191.7 99.4
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
46Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
19 ADIH000528Yellow,
crystalline powder.
Complies Complies
0.01 0.05 Less than 10 ppm
190.2 100.1
20 ADIH001405Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.1 99.8
21 ADIH001358Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.9 99.5
22 ADIH001357Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
191.6 100.3
23 ADIH001356Yellow,
crystalline powder.
Complies Complies
0.03 0.3 Less than 10 ppm
192.2 100.2
24 ADIH000037Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.9 99.4
25 ADIH000006Yellow,
crystalline powder.
Complies Complies
0.03 0.09 Less than 10 ppm
191.2 99.1
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
47Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
26 ADIH000005Yellow,
crystalline powder.
Complies Complies
0.02 0.3 Less than 10 ppm
190.2 99.2
27 ADHH003942Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.9 99.7
28 ADHH003941Yellow,
crystalline powder.
Complies Complies
0.01 0.0 Less than 10 ppm
191.8 99.8
29 ADHH003940Yellow,
crystalline powder.
Complies Complies
0.02 0.0 Less than 10 ppm
191.8 99.5
30 ADHH003939Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.7 100.0
31 ADHH003915Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.0 99.9
32 ADIH000527Yellow,
crystalline powder.
Complies Complies
0.02 0.07 Less than 10 ppm
191.2 99.8
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
48Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
33 ADIH000526Yellow,
crystalline powder.
Complies Complies
0.02 0.08 Less than 10 ppm
192.9 99.5
34 ADIH000525Yellow,
crystalline powder.
Complies Complies
0.02 0.05 Less than 10 ppm
192.2 99.6
35 ADIH000524Yellow,
crystalline powder.
Complies Complies
0.03 0.06 Less than 10 ppm
191.3 100.0
36 ADIH000340Yellow,
crystalline powder.
Complies Complies
0.01 0.04 Less than 10 ppm
191.8 100.1
37 ADIH000339Yellow,
crystalline powder.
Complies Complies
0.02 0.06 Less than 10 ppm
191.2 100.5
38 ADIH000303Yellow,
crystalline powder.
Complies Complies
0.02 0.07 Less than 10 ppm
192.0 100.2
39 ADIH000302Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.0 99.9
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
49Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
40 ADHH003528Yellow,
crystalline powder.
Complies Complies
0.02 0.3 Less than 10 ppm
191.0 99.9
41 ADHH003527Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
191.0 99.7
42 ADHH003500Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.3 99.4
43 ADHH003499Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.4 99.5
44 ADHH003241Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
191.4 99.8
45 ADHH003240Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.9 99.2
46 ADHH003196Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.3 100.2
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
50Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
47 ADIH001275Yellow,
crystalline powder.
Complies Complies
0.02 0.3 Less than 10 ppm
192.2 100.1
48 ADIH001249Yellow,
crystalline powder.
Complies Complies
0.02 0.3 Less than 10 ppm
192.6 98.5
49 ADIH000942Yellow,
crystalline powder.
Complies Complies
0.03 0.4 Less than 10 ppm
191.8 99.8
50 ADIH001274Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.9 99.6
51 ADIH000903Yellow,
crystalline powder.
Complies Complies
0.03 0.2 Less than 10 ppm
191.8 99.1
52 ADIH000529Yellow,
crystalline powder.
Complies Complies
0.02 0.05 Less than 10 ppm
191.2 99.7
53 ADIH000579Yellow,
crystalline powder.
Complies Complies
0.02 0.09 Less than 10 ppm
191.9 99.9
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
51Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
54 ADIH000905Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
192.1 99.6
55 ADIH000906Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
190.1 99.7
56 ADIH000989Yellow,
crystalline powder.
Complies Complies
0.03 0.4 Less than 10 ppm
192.5 99.8
57 ADIH001101Yellow,
crystalline powder.
Complies Complies
0.04 0.1 Less than 10 ppm
191.8 99.7
58 ADIH000988Yellow,
crystalline powder.
Complies Complies
0.03 0.4 Less than 10 ppm
191.9 99.9
59 ADIH000983Yellow,
crystalline powder.
Complies Complies
0.02 0.5 Less than 10 ppm
192.2 100.4
60 ADIH000982Yellow,
crystalline powder.
Complies Complies
0.03 0.4 Less than 10 ppm
191.0 99.3
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
52Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
61 ADIH001102Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.0 99.6
62 ADIH001103Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.8 99.4
63 ADIH000817Yellow,
crystalline powder.
Complies Complies
0.02 0.06 Less than 10 ppm
191.4 99.3
64 ADIH000816Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.1 99.5
65 ADIH001105Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
192.0 98.6
66 ADIH000815Yellow,
crystalline powder.
Complies Complies
0.01 0.08 Less than 10 ppm
191.8 99.4
67 ADIH000580Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
191.9 99.7
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
53Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
68 ADIH000814Yellow,
crystalline powder.
Complies Complies
0.04 0.08 Less than 10 ppm
192.5 99.3
69 ADIH000796Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
191.3 99.4
70 ADIH000904Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.3 99.4
71 ADIH000664Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
191.0 99.9
72 ADIH000663Yellow,
crystalline powder.
Complies Complies
0.02 0.09 Less than 10 ppm
190.6 99.8
73 ADIH001104Yellow,
crystalline powder.
Complies Complies
0.01 0.2 Less than 10 ppm
191.7 99.0
74 ADIH001106Yellow,
crystalline powder.
Complies Complies
0.03 0.1 Less than 10 ppm
191.9 99.3
ANNUAL REVIEW REPORT- PRODUCT
This document is electronically generated.
CTO UNIT-IV
54Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
75 ADIH000610Yellow,
crystalline powder.
Complies Complies
0.03 0.08 Less than 10 ppm
191.5 99.8
76 ADIH000609Yellow,
crystalline powder.
Complies Complies
0.02 0.09 Less than 10 ppm
191.7 99.3
77 ADIH001191Yellow,
crystalline powder.
Complies Complies
0.01 0.3 Less than 10 ppm
190.6 100.4
78 ADIH001192Yellow,
crystalline powder.
Complies Complies
0.02 0.6 Less than 10 ppm
192.1 99.9
79 ADIH001241Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.7 99.4
80 ADIH001194Yellow,
crystalline powder.
Complies Complies
0.03 0.3 Less than 10 ppm
192.0 100.1
MEAN-BY SYSTEM NA NA NA 0.0199 0.1803 NA 191.7113 99.7188
SIGMA-BY SYSTEM NA NA NA 0.0100 0.1217 NA 0.6238 0.4329
ANNUAL REVIEW REPORT- PRODUCT
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55Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
+3 SIGMA-BY SYSTEM NA NA NA 0.0499 0.5454 NA 193.5827 101.0175
-3 SIGMA-BY SYSTEM NA NA NA -0.0101 -0.1848 NA 189.8399 98.4201
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
1 ADHH003195 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12Less than LOQ (LOQ:0.009%)
2 ADHH003163 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
3 ADHH003162 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
4 ADHH003914 Not detected 0.08 Not detected Not detected Not detected Not detected
0.12 Not detected
5 ADHH003860 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
6 ADHH003859 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12Less than LOQ (LOQ:0.009%)
7 ADHH003857 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
8 ADHH003856 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
9 ADHH003855 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12 Not detected
ANNUAL REVIEW REPORT- PRODUCT
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56Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
10 ADHH003849 Not detected 0.09 Not detected Not detected Not detected Not detected
0.14Less than LOQ (LOQ:0.009%)
11 ADHH003697 Not detected 0.06 Not detected Not detected Not detected Not detected
0.1 Not detected
12 ADHH003696 Not detected 0.06 Not detected Not detected Not detected Not detected
0.10 Not detected
13 ADHH003668 Not detected 0.08 Not detected Not detected Not detected Not detected
0.12 Not detected
14 ADHH003638 Not detected 0.05 Not detected Not detected Not detected Not detected
0.07 Not detected
15 ADHH003637 Not detected 0.06 Not detected Not detected Not detected Not detected
0.08 Not detected
16 ADHH003615 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12 Not detected
17 ADHH003612 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12 Not detected
18 ADHH003587 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12 Not detected
19 ADIH000528 Not detected 0.07 Not detected Not detected Not detected
Below disregarding
limit(BDL:0.05%)
0.12 Not detected
ANNUAL REVIEW REPORT- PRODUCT
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57Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
20 ADIH001405 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13
Below limit of detection
(LOD:0.002%)
21 ADIH001358 Not detected 0.07 Not detected
0.01 Not detectedBelow
disregard limit(BLD:0.05%)
0.12
Less than LOQ(LOQ:0.009%)
22 ADIH001357 Notdetected 0.08 Notdetected Notdetected Notdetected Notdetected
0.11 Notdetected
23 ADIH001356 Notdetected 0.08 Notdetected Notdetected Notdetected Notdetected
0.12 Notdetected
24 ADIH000037 Not detected 0.06 Not detected Not detected Not detected Not detected
0.10 Not detected
25 ADIH000006 Not detected 0.06 Not detected Not detected Not detected Not detected
0.09 Not detected
26 ADIH000005 0.01 0.07 Not detected Not detected Not detected Not detected
0.13 Not detected
27 ADHH003942 Not detected 0.06 Not detected Not detected Not detected Not detected
0.11 Not detected
28 ADHH003941 Not detected 0.06 Not detected Not detected Not detected Not detected
0.10 Not detected
29 ADHH003940 Not detected 0.07 Not detected Not detected Not detected Not detected
0.11 Not detected
ANNUAL REVIEW REPORT- PRODUCT
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58Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
30 ADHH003939 Not detected 0.06 Not detected Not detected Not detected Not detected
0.10 Not detected
31 ADHH003915 Not detected 0.08 Not detected Not detected Not detected Not detected
0.12 Not detected
32 ADIH000527 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
33 ADIH000526 Not detected 0.07 Not detected Not detected Not detected Not detected
0.11 Not detected
34 ADIH000525 Not detected 0.07 Not detected Not detected Not detected Not detected
0.10 Not detected
35 ADIH000524 Not detected 0.07 Not detected Not detected Not detected Not detected
0.10 Not detected
36 ADIH000340 Not detected 0.06 Not detected Not detected Not detected Not detected
0.10 Not detected
37 ADIH000339 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12 Not detected
38 ADIH000303 Not detected 0.09 Not detected Not detected Not detected Not detected
0.12 Not detected
39 ADIH000302 Not detected 0.07 Not detected Not detected Not detected Not detected
0.11 Not detected
40 ADHH003528 Not detected 0.07 Not detected Not detected Not detected Not detected
0.10 Not detected
ANNUAL REVIEW REPORT- PRODUCT
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59Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
41 ADHH003527 Not detected 0.07 Not detected Not detected Not detected 0.06
0.17 Not detected
42 ADHH003500 Not detected 0.07 Not detected Not detected Not detected Not detected
0.1 Not detected
43 ADHH003499 Not detected 0.07 Not detected Not detected Not detected Not detected
0.1 Not detected
44 ADHH003241 Not detected 0.06 Not detected Not detected Not detected Not detected
0.12Less than LOQ (LOQ:0.009%)
45 ADHH003240 Not detected 0.07 Not detected Not detected Not detected Not detected
0.13Less than LOQ (LOQ:0.009%)
46 ADHH003196 Not detected 0.08 Not detected Not detected Not detected Not detected
0.12Less than LOQ (LOQ:0.009%)
47 ADIH001275 Not detected 0.07 Not detected Not detected Not detected 0.07
0.19 Not detected
48 ADIH001249 Not detected 0.10 Not detected Not detected Not detected Not detected
0.16 Not detected
49 ADIH000942 Notdetected 0.08 Notdetected Notdetected Notdetected
Below disregarding
limit(BDL:0.05%)
0.13 Notdetected
50 ADIH001274 Not detected 0.10 Not detected Not detected Not detected Not detected
0.14 Not detected
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60Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
51 ADIH000903 Not detected 0.06 Not detected Not detected Not detected Not detected
0.11 Not detected
52 ADIH000529 Not detected 0.07 Not detected Not detected Not detected
Below disregarding
limit(BDL:0.05%)
0.12 Not detected
53 ADIH000579 Not detected 0.08 Not detected Not detected Not detected
Below disregarding
limit(BDL:0.05%)
0.13 Not detected
54 ADIH000905 Notdetected 0.08 Notdetected Notdetected Notdetected Notdetected
0.12
Below limit of detection
(LOD:0.002%)
55 ADIH000906 Not detected 0.07 Not detected Not detected Not detected Not detected
0.12
Below limit of detection
(LOD:0.002%)
56 ADIH000989 Not detected 0.06 Not detected Not detected Not detectedBelow
disregard limit(BDL:0.05%)
0.11
Less than LOQ(LOQ:0.009%)
57 ADIH001101 Notdetected 0.08 Notdetected Notdetected Notdetected
Below disregarding
limit(BDL:0.05%)
0.12 Notdetected
58 ADIH000988 Not detected 0.08 Not detected Not detected Not detectedBelow
disregarding limit (0.05%)
0.13
Less than LOQ (LOQ:0.009%)
ANNUAL REVIEW REPORT- PRODUCT
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61Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
59 ADIH000983 Not detected 0.07 Not detected Not detected Not detectedBelow
disregard limit(BDL0.05%)
0.11
Less than LOQ(LOQ:0.009%)
60 ADIH000982 Notdetected 0.07 Notdetected Notdetected Notdetected
Below disregarding
limit(BDL:0.05%)
0.12
Less than LOQ(LOQ:0.009%)
61 ADIH001102 Not detected 0.09 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.14 Not detected
62 ADIH001103 Not detected 0.07 Not detected Not detected Not detected
Below Disregarding
Limit(BDL:0.05%)
0.13 Not detected
63 ADIH000817 Not detected 0.08 Not detected Not detected Not detected Not detected
0.11
Below limit of detection
(LOD:0.002%)
64 ADIH000816 Not detected 0.06 Not detected Not detected Not detected Not detected
0.11
Below limit of detection
(LOD:0.002%)
65 ADIH001105 Notdetected 0.09 Notdetected Notdetected Notdetected
Below disregarding
limit(BDL:0.05%)
0.14 Notdetected
66 ADIH000815 Not detected 0.11 Not detected Not detected Not detected Not detected
0.16Less than LOQ(LOQ:0.009%)
ANNUAL REVIEW REPORT- PRODUCT
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62Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
67 ADIH000580 Not detected 0.08 Not detected Not detected 0.03
Below disregarding
limit (BDL:0.05%)
0.16 Not detected
68 ADIH000814 Not detected 0.07 Not detected Not detected Not detected Not detected
0.11
Below limit of detection
(LOD:0.002%)
69 ADIH000796 Less than LOQ(LOQ:0.003%)
0.07 Not detected Not detected Not detected Not detected
0.11
Below limit of detection
(LOD:0.002%)
70 ADIH000904 Not detected 0.07 Not detected Not detected Not detected Not detected
0.13
Below limit of detection
(LOD:0.002%)
71 ADIH000664 Not detected 0.10 Not detected Not detected Not detected Not detected
0.14 Not detected
72 ADIH000663 Not detected 0.09 Not detected Not detected Not detected Not detected
0.14 Not detected
73 ADIH001104 Not detected 0.07 Not detected Not detected Not detectedBelow
disregard limit(BDL:0.05%)
0.12 Not detected
74 ADIH001106 Not detected 0.08 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.13 Not detected
ANNUAL REVIEW REPORT- PRODUCT
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63Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
75 ADIH000610 Not detected 0.09 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.15 Not detected
76 ADIH000609 Not detected 0.08 Not detected Not detected Not detected
Below disregarding
limit(BDL:0.05%)
0.12 Not detected
77 ADIH001191 Not detected 0.08 Not detected Not detected Not detected Not detected
0.14 Not detected
78 ADIH001192 Not detected 0.08 Not detected Not detected Not detected Not detected
0.13 Not detected
79 ADIH001241 Not detected 0.07 Not detected Not detected Not detected Not detected
0.11 Not detected
80 ADIH001194 Not detected 0.08 Not detected Not detected Not detected Not detected
0.12 Not detected
MEAN-BY SYSTEM 0.0001 0.0744 0.0000 0.0001 0.0004 0.0016 0.1213 0.0000
SIGMA-BY SYSTEM 0.0000 0.0100 0.0000 0.0000 0.0000 0.0100 0.0200 0.0000
+3 SIGMA-BY SYSTEM
0.0001 0.1044 0.0000 0.0001 0.0004 0.0316 0.1813 0.0000
-3 SIGMA-BY SYSTEM
0.0001 0.0444 0.0000 0.0001 0.0004 -0.0284 0.0613 0.0000
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64Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
1 ADHH003195 0.04 Less than LOQ (LOQ:0.008%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
2 ADHH003163 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
3 ADHH003162 0.05 Not detected Not detected
137 Not detected Not detected Not detected Not detected
4 ADHH003914 0.04 Not detected Not detected
176 Not detected Not detected Not detected Not detected
5 ADHH003860 0.05 Not detected Not detected
183 Not detected Not detected Not detected
Less than LOQ (LOQ:32.1ppm)
6 ADHH003859 0.05 Less than LOQ (LOQ:0.008%)
Not detected
171 Not detected Not detected Not detected Not detected
7 ADHH003857 0.04 Less than LOQ (LOQ:0.008%)
Not detected
196 Not detected Not detected Not detected Not detected
8 ADHH003856 0.04 Less than LOQ (LOQ:0.008%)
Not detected
157 Not detected Not detected Not detected Not detected
ANNUAL REVIEW REPORT- PRODUCT
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65Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
9 ADHH003855 0.05 Less than LOQ (LOQ:0.008%)
Not detected
145 Not detected Not detected Not detected Not detected
10 ADHH003849 0.04 Less than LOQ (LOQ:0.008%)
Not detected
163 Not detected Not detected Not detected Not detected
11 ADHH003697 0.05 Not detected Not detected
148 Not detectedLess than LOQ (LOQ:112.5pp
m)
Not detected Not detected
12 ADHH003696 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
13 ADHH003668 0.04 Not detected Not detected
143 Not detectedLess than LOQ (LOQ:112.5pp
m)
Not detected Not detected
14 ADHH003638 0.02 Not detected Not detected
138 Not detected Not detected Not detected Not detected
15 ADHH003637 0.02 Not detected Not detected
144 Not detected Not detected Not detected Not detected
16 ADHH003615 0.05 Not detected Not detected
143 Not detected Not detected Not detected Not detected
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66Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
17 ADHH003612 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
18 ADHH003587 0.05 Not detected Not detected
171 Not detected Not detected Not detected Not detected
19 ADIH000528 0.05 Not detected Not detected
164 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
20 ADIH001405 0.04 Less than LOQ(LOQ:0.008%)
Not detected
173 Not detected Not detected Not detected Not detected
21 ADIH001358 0.04Below limit of
detection(LOD:0.002%)
Not detected
156 Not detected Not detected Not detected
Below limit of detection
(LOD:9.6ppm)
22 ADIH001357 0.03 Notdetected Notdetected
136 Notdetected Notdetected Notdetected
Below limit of detection
(LOD:9.6ppm)
23 ADIH001356 0.04 Notdetected Notdetected
Less than LOQ
(LOQ:135.9ppm)
Below limit of detection
(LOD:40.3ppm)
Below limit of detection
(LOD:33.8ppm)
Notdetected
Below limit of detection
(LOD:9.6ppm)
ANNUAL REVIEW REPORT- PRODUCT
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67Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
24 ADIH000037 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
25 ADIH000006 0.03 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
26 ADIH000005 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
27 ADHH003942 0.04 Not detected Not detected
192 Not detected Not detected Not detected Not detected
28 ADHH003941 0.04 Not detected Not detected Not detected 193 Not detected Not detected Not detected
29 ADHH003940 0.04 Not detected Not detected
155 Not detected Not detected Not detected Not detected
30 ADHH003939 0.04 Not detected Not detected
158 Not detected Not detected Not detected Not detected
31 ADHH003915 0.03 Not detected Not detected
150 Not detected Not detected Not detected Not detected
ANNUAL REVIEW REPORT- PRODUCT
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68Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
32 ADIH000527 0.05 Not detected Not detected
141 Not detected Not detected Not detected Not detected
33 ADIH000526 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
34 ADIH000525 0.04 Not detected Not detected
142 Not detected Not detected Not detected Not detected
35 ADIH000524 0.04 Not detected Not detected
143 Not detected Not detected Not detected Not detected
36 ADIH000340 0.04 Not detected Not detected
146 Not detected Not detected Not detected Not detected
37 ADIH000339 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
38 ADIH000303 0.03 Not detected Not detected
205 Not detected Not detected Not detected Not detected
39 ADIH000302 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detectedLess than LOQ (LOQ:112.5pp
m)
Not detected Not detected
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CTO UNIT-IV
69Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
40 ADHH003528 0.03 Not detected Not detected
172 Not detected Not detected Not detected Not detected
41 ADHH003527 0.04 Not detected Not detected
276 Not detected Not detected Not detected Not detected
42 ADHH003500 0.04 Not detected Not detected
262 Not detectedLess than LOQ (LOQ:112.5pp
m)%)
Not detected Not detected
43 ADHH003499 0.04 Not detected Not detected
271 Not detected Not detected Not detected Not detected
44 ADHH003241 0.05 Not detected Not detected
199 Not detected Not detected Not detected Not detected
45 ADHH003240 0.05 Not detected Not detected
197 Not detected Not detected Not detected Not detected
46 ADHH003196 0.03 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
47 ADIH001275 0.05 Not detected Not detected
143 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
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70Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
48 ADIH001249 0.05 Not detected Not detected
158 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
49 ADIH000942 0.04 Notdetected Notdetected
168 NotdetectedLess than LOQ(LOQ:112.5pp
m)
Notdetected Notdetected
50 ADIH001274 0.04 Not detected Not detected
144 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
51 ADIH000903 0.05Below limit of
detection(LOD:0.002%)
Not detected
153 Not detected
Below limit of detection
(LOD:33.8 ppm)
Not detected Not detected
52 ADIH000529 0.05 Not detected Not detected
147 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
53 ADIH000579 0.05 Not detected Not detected
262 Not detected 120 Not detected
Less than LOQ(LOQ:32.1ppm)
54 ADIH000905 0.04 Notdetected Notdetected
213 Notdetected
Below limit of detection
(LOD:33.8ppm)
Notdetected
Below limit of detection
(LOD:9.6ppm)
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71Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
55 ADIH000906 0.05Below limit of
detection(LOD:0.002%)
Not detected
180 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
56 ADIH000989 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Below limit of detection
(LOD:40.3ppm)
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
57 ADIH001101 0.03 Notdetected Notdetected
Less than LOQ
(LOQ:135.9ppm)
Below limit of detection
(LOD:40.3ppm)Notdetected Notdetecte
d
Below limit of detection
(LOD:9.6ppm)
58 ADIH000988 0.05 Not detected Not detected
159 Not detected
Below limit of detection(LOD:
33.8ppm)
Not detected
Below limit of detection(LOD:
9.6ppm)
59 ADIH000983 0.04 Not detected Not detected
160 Not detectedLess than LOQ(LOQ:112.5pp
m)
Not detected Not detected
60 ADIH000982 0.04 Notdetected Notdetected
176 NotdetectedLess than LOQ(LOQ:112.5pp
m)
Notdetected Notdetected
61 ADIH001102 0.05 Not detected Not detected
153 Not detected Not detected Not detected Not detected
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72Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
62 ADIH001103 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Below limit of detection
(LOD:40.3ppm)Not detected Not
detected
Below limit of detection
(LOD:9.6ppm)
63 ADIH000817 0.03 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
64 ADIH000816 0.05Below limit of
detection(LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
65 ADIH001105 0.05 Notdetected Notdetected
145 Notdetected Notdetected Notdetected Notdetected
66 ADIH000815 0.04Below limit of
detection(LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
67 ADIH000580 0.05 Not detected
Below limit of detection
(LOD:17.8ppm)
205
Below limit of detection
(LOD:40.3ppm) 130 Not
detected
Below limit of detection
(LOD:9.6ppm)
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73Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
68 ADIH000814 0.04 Less than LOQ(LOQ:0.008%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
69 ADIH000796 0.04 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
70 ADIH000904 0.06Below limit of
detection(LOD:0.002%)
Not detected
207 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
71 ADIH000664 0.04 Not detected Not detected
147 Not detected Not detected Not detected
Below limit of detection
(LOD:9.6ppm)
72 ADIH000663 0.04 Not detected Not detected
140 Not detected Not detected Not detected Not detected
73 ADIH001104 0.05 Not detected Not detected
166
Below limit of detection
(LOD:40.3ppm)Not detected Not
detected
Below limit of detection
(LOD:9.6ppm)
74 ADIH001106 0.05 Not detected Not detected
Less than LOQ
(LOQ:135.9 ppm)
Not detected Not detected Not detected Not detected
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74Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
75 ADIH000610 0.06 Not detected
Less than LOQ
(LOQ:59.1ppm)
197
Below limit of detection
(LOD:40.3ppm)
Less than LOQ(LOQ:112.5pp
m)
Not detected
Less than LOQ(LOQ:32.1ppm)
76 ADIH000609 0.04 Not detected
Less than LOQ
(LOQ:59.1 ppm)
225
Less than LOQ (LOQ:133.4
ppm)) 117 Not
detectedLess than LOQ
(LOQ:32.1 ppm)
77 ADIH001191 0.06Below limit of
detection(LOD:0.002%)
Not detected
189 Not detected Not detected Not detected Not detected
78 ADIH001192 0.05 Not detected Not detected
209 Not detected Not detected Not detected Not detected
79 ADIH001241 0.04 Not detected Not detected
164
Below limit of detection
(LOD:40.3ppm)
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
80 ADIH001194 0.04 Not detected Not detected
175 Not detected
Below limit of detection(LOD:
33.8ppm)
Not detected
Below limit of detection(LOD:
9.6ppm)
MEAN-BY SYSTEM 0.0430 0.0000 0.0000 125.4750 2.4125 4.5875 0.0000 0.0000
SIGMA-BY SYSTEM 0.0100 0.0000 0.0000 83.1066 21.5781 23.4130 0.0000 0.0000
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75Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
+3 SIGMA-BY SYSTEM
0.0730 0.0000 0.0000 374.7948 67.1468 74.8265 0.0000 0.0000
-3 SIGMA-BY SYSTEM
0.0130 0.0000 0.0000 -123.8448 -62.3218 -65.6515 0.0000 0.0000
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
1 ADHH003195 450 Not detected Not detected Complies 100 100
100 0.61
2 ADHH003163 Not detected Not detected Not detected Complies 100 100
100 0.57
3 ADHH003162 Not detected Not detected Not detected Complies 100 100
100 0.54
4 ADHH003914 Not detected Not detected Not detected Complies 100 100
99 0.58
5 ADHH003860 Not detected Not detected Not detected Complies 100 100
99 0.58
6 ADHH003859 Not detected Not detected Not detected Complies 100 100
100 0.65
ANNUAL REVIEW REPORT- PRODUCT
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76Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
7 ADHH003857 Not detected Not detected Not detected Complies 100 100
100 0.64
8 ADHH003856 Not detected Not detected Not detected Complies 100 100
97 0.57
9 ADHH003855 Not detected Not detected Not detected Complies 100 100
100 0.53
10 ADHH003849 Not detected Not detected Not detected Complies 100 100
100 0.60
11 ADHH003697 Not detected Not detected Not detected Complies 100 100
100 0.57
12 ADHH003696 Not detected Not detected Not detected Complies 100 100
99 0.63
13 ADHH003668 Not detected Not detected Not detected Complies 100 100
100 0.55
14 ADHH003638 159 Not detected Not detected Complies 100 100
99 0.59
15 ADHH003637 153 Not detected Not detected Complies 100 100
94 0.64
ANNUAL REVIEW REPORT- PRODUCT
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77Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
16 ADHH003615 Not detected Not detected Not detected Complies 100 100
100 0.62
17 ADHH003612 Not detected Not detected Not detected Complies 100 100
100 0.60
18 ADHH003587 Not detected Not detected Not detected Complies 100 100
100 0.57
19 ADIH000528 190 Not detected Not detected Complies 100 100
100 0.62
20 ADIH001405 159 Not detected Not detected Complies 99 98
89 0.60
21 ADIH001358Less than LOQ(LOQ:147.7pp
m)Not detected Not detected Complies 100 100
99 0.59
22 ADIH001357Below limit of
detection(LOD:44.4ppm)
Notdetected Notdetected Complies 100 100
99 0.57
23 ADIH001356Below limit of
detection(LOD:44.4ppm)
Notdetected Notdetected Complies 100 100
99 0.55
ANNUAL REVIEW REPORT- PRODUCT
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78Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
24 ADIH000037Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.64
25 ADIH000006Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.64
26 ADIH000005Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.63
27 ADHH003942Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.62
28 ADHH003941 Not detected Not detected Not detected Complies 100 100
100 0.62
29 ADHH003940 Not detected Not detected Not detected Complies 100 100
100 0.60
30 ADHH003939Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
99 0.62
ANNUAL REVIEW REPORT- PRODUCT
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79Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
31 ADHH003915Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
96 0.55
32 ADIH000527 Not detected Not detected Not detected Complies 100 100
100 0.54
33 ADIH000526 Not detected Not detected Not detected Complies 100 100
100 0.58
34 ADIH000525 Not detected Not detected Not detected Complies 100 100
100 0.58
35 ADIH000524 Not detected Not detected Not detected Complies 100 100
100 0.63
36 ADIH000340 Not detected Not detected Not detected Complies 100 100
100 0.62
37 ADIH000339 Not detected Not detected Not detected Complies 100 100
100 0.58
38 ADIH000303 Not detected Not detected Not detected Complies 100 100
100 0.60
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80Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
39 ADIH000302 546 Not detected Not detected Complies 100 100
100 0.64
40 ADHH003528 Not detected Not detected Not detected Complies 100 100
99 0.59
41 ADHH003527 332 Not detected Not detected Does not comply 100 100
100 0.59
42 ADHH003500 543 Not detected Not detected Does not comply 100 100
100 0.61
43 ADHH003499 348 Not detected Not detected Does not comply 100 100
98 0.58
44 ADHH003241 Not detected Not detected Not detected Complies 100 100
100 0.63
45 ADHH003240Less than LOQ (LOQ:147.7PP
m)Not detected Not detected Complies 100 100
100 0.66
46 ADHH003196Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.54
ANNUAL REVIEW REPORT- PRODUCT
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81Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
47 ADIH001275Below limit of
detection(LOD:44.4ppm)
Not detected Not detected Complies 99 98
94 0.56
48 ADIH001249Less than LOQ(LOQ:147.7pp
m)Not detected Not detected Complies 100 100
96 0.55
49 ADIH000942Less than LOQ(LOQ:147.7pp
m)Notdetected Notdetected Complies 100 100
100 0.55
50 ADIH001274Less than LOQ(LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.56
51 ADIH000903 Not detected Not detected Not detected Complies 100 100
100 0.58
52 ADIH000529 223 Not detected Not detected Complies 100 100
100 0.58
53 ADIH000579 251 Less than LOQ(LOQ:56.5ppm)
Not detected Complies 100 100
99 0.65
54 ADIH000905 Notdetected Notdetected Notdetected Complies 100 100
100 0.56
ANNUAL REVIEW REPORT- PRODUCT
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82Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
55 ADIH000906 Not detected Not detected Not detected Complies 100 100
99 0.58
56 ADIH000989 Not detected Not detected Not detected Complies 100 100
100 0.59
57 ADIH001101 Notdetected Notdetected Notdetected Complies 100 100
97 0.57
58 ADIH000988Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.58
59 ADIH000983Less than LOQ(LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.57
60 ADIH000982Less than LOQ(LOQ:147.7pp
m)Notdetected Notdetected Complies 100 100
100 0.56
61 ADIH001102 Not detected Not detected Not detected Complies 100 100
97 0.58
62 ADIH001103 Not detected Not detected Not detected Complies 100 100
98 0.58
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83Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
63 ADIH000817 Not detected Not detected Not detected Complies 100 100
100 0.58
64 ADIH000816 Not detected Not detected Not detected Complies 100 100
100 0.51
65 ADIH001105 Notdetected Notdetected Notdetected Complies 100 100
99 0.59
66 ADIH000815 Not detected Not detected Not detected Complies 100 100
99 0.54
67 ADIH000580Less than LOQ(LOQ:147.7pp
m)Not detected Not detected Complies 100 100
99 0.60
68 ADIH000814 Not detected Not detected Not detected Complies 100 100
99 0.57
69 ADIH000796 Not detected Not detected Not detected Complies 100 100
98 0.55
70 ADIH000904 Not detected Not detected Not detected Complies 100 100
100 0.56
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
71 ADIH000664 264 Not detected Not detected Does not comply 100 100
100 0.62
72 ADIH000663 Not detected Not detected Not detected Complies 100 100
100 0.60
73 ADIH001104 Not detected Not detected Not detected Complies 100 100
99 0.56
74 ADIH001106 Not detected Not detected Not detected Complies 100 100
98 0.57
75 ADIH000610 253 Not detected Not detected Complies 100 100
100 0.59
76 ADIH000609 158 Not detected Not detected Complies 100 100
100 0.62
77 ADIH001191 Not detected Not detected Not detected Complies 100 100
98 0.55
78 ADIH001192 Not detected Not detected Not detected Complies 100 100
99 0.60
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85Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
79 ADIH001241Below limit of
detection(LOD:44.4ppm)
Not detected Not detected Complies 100 100
95 0.59
80 ADIH001194Below limit of detection(LOD:
44.4ppm)Not detected Not detected Complies 100 100
100 0.55
MEAN-BY SYSTEM 50.3625 0.0000 0.0000 NA 99.9750 99.9500 99.1000 0.5876
SIGMA-BY SYSTEM 123.5218 0.0000 0.0000 NA 0.1572 0.3142 1.7761 0.0316
+3 SIGMA-BY SYSTEM
420.9279 0.0000 0.0000 NA 100.4466 100.8926 104.4283 0.6824
-3 SIGMA-BY SYSTEM
-320.2029 0.0000 0.0000 NA 99.5034 99.0074 93.7717 0.4928
QA FINAL COMMENTS
Total no. of batches analyzed during the review period: 80 No. ofbatches approved during the review period: 74 No. of batches rejectedduring this review period: 6 No. of batches falling outside +3Sigma: 0
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 50.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 90.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Tapped density (LIMIT:):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,
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87Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Assay by HPLC (Onanhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Melting Point( Limit:Between188.0 and 194.0 °C):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC (Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC(Method-1) ( Limit: NMT 0.1 %):ADIH000005,ADIH000580,ADIH001358 Related Substances by HPLC(Method-1) ( Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,
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88Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Created By :HP -Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:52:02 okreviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 05/10/2015 at 21:52:02 reviewed Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:35:08 OkReviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 12/10/2015 at 14:43:43 ssss Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 12/10/2015 at16:47:04 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:08:11 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:08:33 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:28:50 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :
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89Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
21/10/2015 at20:27:18 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:34:28 stested by pandu Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:16:35 SSSSSast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:05:09
19.1.2 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of
S-08-OI-Ph.Eur/02Specification Ref. No.
20.00Scale
NOT APPLICABLEValidation Form No.
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
1 ADIH001663Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
192.2 100.2
2 ADIH001640Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
192.1 100.1
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90Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
3 ADIH001193Yellow,
crystalline powder.
Complies Complies
0.04 0.2 Less than 10 ppm
191.8 99.5
4 ADIH001584Yellow,
crystalline powder.
Complies Complies
0.04 0.1 Less than 10 ppm
191.2 100.1
5 ADIH001583Yellow,
crystalline powder.
Complies Complies
0.02 0.09 Less than 10 ppm
190.7 100.5
6 ADIH001884Yellow,
crystalline powder.
Complies Complies
0.03 0.1 Less than 10 ppm
191.5 100.3
7 ADIH001910Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
190.1 100.9
8 ADIH001911Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
192.8 99.3
9 ADIH001935Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.2 99.8
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91Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
10 ADIH001936Yellow,
crystalline powder.
Complies Complies
0.01 0.07 Less than 10 ppm
191.9 99.0
11 ADIH001883Yellow,
crystalline powder.
Complies Complies
0.02 0.07 Less than 10 ppm
192.2 100.3
12 ADIH001882Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
190.9 99.0
13 ADIH001835Yellow,
crystalline powder.
Complies Complies
0.03 0.1 Less than 10 ppm
191.9 99.3
14 ADIH001834Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
190.2 99.1
15 ADIH001987Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.2 99.7
16 ADIH001988Yellow,
crystalline powder.
Complies Complies
0.02 0.09 Less than 10 ppm
193.0 100.1
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92Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
17 ADIH002007Yellow,
crystalline powder.
Complies Complies
0.03 0.1 Less than 10 ppm
191.4 100.1
18 ADIH002009Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
192.0 100.0
19 ADIH001833Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
191.9 100.0
20 ADIH001666Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.1 99.8
21 ADIH001725Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.4 99.7
22 ADIH001724Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
190.3 99.8
23 ADIH001419Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
190.7 101.3
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93Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Appearance ( LIMIT: Yellow, crystalline powder.)
Solubility ( LIMIT: Practically insoluble in water, freely Soluble in methylene chloride, slightly Soluble in ethanol (96%))
Identification by IR ( LIMIT: To match with working standard)
Sulphated ash ( Limit: NMT 0.1 %w/w )
Water ( Limit: NMT 1.0 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting Point( Limit: Between188.0 and 194.0 °C )
Assay by HPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w )
24 ADIH001474Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.1 100.0
25 ADIH001667Yellow,
crystalline powder.
Complies Complies
0.02 0.2 Less than 10 ppm
189.9 99.8
26 ADIH001475Yellow,
crystalline powder.
Complies Complies
0.02 0.07 Less than 10 ppm
191.7 100.5
27 ADIH001579Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.4 99.3
28 ADIH001580Yellow,
crystalline powder.
Complies Complies
0.02 0.1 Less than 10 ppm
191.3 99.8
29 ADIH001581Yellow,
crystalline powder.
Complies Complies
0.01 0.1 Less than 10 ppm
192.2 100.4
30 ADIH001582Yellow,
crystalline powder.
Complies Complies
0.03 0.1 Less than 10 ppm
192.1 100.1
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94Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
MEAN-BY SYSTEM NA NA NA 0.0200 0.1163 NA 191.5467 99.9267
SIGMA-BY SYSTEM NA NA NA 0.0100 0.0436 NA 0.7895 0.5310
+3 SIGMA-BY SYSTEM NA NA NA 0.0500 0.2471 NA 193.9152 101.5197
-3 SIGMA-BY SYSTEM NA NA NA -0.0100 -0.0145 NA 189.1782 98.3337
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
1 ADIH001663 Not detected 0.08 Not detected Not detected Not detectedBelow
disregard limit (BDL:0.05%)
0.12 Not detected
2 ADIH001640 Notdetected 0.09 Notdetected Notdetected Notdetected
Below disregarding
limit(BDL:0.05%)
0.12
Below limit of detection
(LOD:0.002%)
3 ADIH001193 Not detected 0.08 Not detected
Less than LOQ
(LOQ:0.004%)
Not detectedBelow
Disregard limit(BDL:0.05%)
0.13 Not detected
4 ADIH001584 Notdetected 0.07 Notdetected Notdetected Notdetected Notdetected
0.09 Notdetected
5 ADIH001583 Not detected 0.08 Not detected Not detected Not detected Not detected
0.11 Not detected
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95Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
6 ADIH001884Below limit of
detection (LOD:0.0007%)
0.08
Less than LOQ
(LOQ:0.011 %)
Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.11 Not detected
7 ADIH001910Below limit of
Detection(LOD:0.0007%)
0.07
Less than LOQ
(LOQ:0.011%)
Not detected Not detectedBelow
disregard limit (BDL:0.05%)
0.10 Not detected
8 ADIH001911 Not detected 0.07 Not detected
0.005 Not detectedBelow
disregard limit (BDL:0.05%)
0.12 Not detected
9 ADIH001935 Not detected 0.07 Not detectedLess than
LOQ(LOQ: 0.004%)
Not detected
Below disregarding
limit (BDL:0.05%)
0.09 Not detected
10 ADIH001936 Not detected 0.07 Not detected
Below limit of Detection(LOD:0.004
%)
Not detectedBelow
disregard limit (BDL:0.05%)
0.10 Not detected
11 ADIH001883Below limit of
detection (LOD:0.0007%)
0.07
Less than LOQ
(LOQ:0.011 %)
Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.10 Not detected
12 ADIH001882 Less than LOQ (LOQ:0.003 %)
0.07
Less than LOQ
(LOQ:0.011 %)
Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.11 Not detected
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96Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
13 ADIH001835 Not detected 0.08 Not detected Not detected Not detectedBelow
disregard limit (BDL:0.05%)
0.12
Below limit of Detection
(LOD:0.002%)
14 ADIH001834 Not detected 0.08 Not detected Not detected Not detected Not detected
0.10
Below limit of detection
(LOD:0.002%)
15 ADIH001987 Not detected 0.08 Not detected
Less than LOQ
(LOQ:0.004 %)
Not detected Not detected
0.12 Not detected
16 ADIH001988 Not detected 0.09 Not detected Not detected Not detected Not detected
0.12Less than LOQ (LOQ:0.009%)
17 ADIH002007 Not detected 0.08 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.1 Not detected
18 ADIH002009 Not detected 0.08 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.11 Not detected
19 ADIH001833 Not detected 0.08 Not detected Not detected Not detected Not detected
0.11
Below limit of detection
(LOD:0.002%)
20 ADIH001666 Not detected 0.08 Not detected Not detected Not detectedBelow
disregard limit (BDL:0.05%)
0.10 Not detected
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97Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-1) ( Limit: NMT 0.1 % )
Related Substances by HPLC ( Limit: NMT 0.2 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.2 % )
21 ADIH001725 Not detected 0.09 Not detected Not detected Not detected
Below disregarding
limit (BDL:0.05%)
0.12 Not detected
22 ADIH001724 Not detected 0.07 Not detected
0.01 Not detectedBelow
disregard limit (BDL:0.05%)
0.11 Not detected
23 ADIH001419 Not detected 0.07 Not detected Not detected Not detected Not detected
0.14 Not detected
24 ADIH001474 Not detected 0.07 Not detected Not detected Not detected Not detected
0.14 Not detected
25 ADIH001667 Not detected 0.08 Not detected Not detected Not detectedBelow
disregard limit (BDL:0.05%)
0.10 Not detected
26 ADIH001475 Not detected 0.08 Not detected Not detected Not detected Not detected
0.11 Not detected
27 ADIH001579 Not detected 0.09 Not detected Not detected Not detected Not detected
0.10 Not detected
28 ADIH001580 Not detected 0.09 Not detected Not detected Not detected 0.06
0.15 Not detected
29 ADIH001581 Not detected 0.09 Not detected Not detected Not detected Not detected
0.12 Not detected
30 ADIH001582 Not detected 0.10 Not detected Not detected Not detected Not detected
0.13 Not detected
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98Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
MEAN-BY SYSTEM 0.0000 0.0793 0.0000 0.0005 0.0000 0.0020 0.1133 0.0000
SIGMA-BY SYSTEM 0.0000 0.0100 0.0000 0.0000 0.0000 0.0100 0.0141 0.0000
+3 SIGMA-BY SYSTEM
0.0000 0.1093 0.0000 0.0005 0.0000 0.0320 0.1556 0.0000
-3 SIGMA-BY SYSTEM
0.0000 0.0493 0.0000 0.0005 0.0000 -0.0280 0.0710 0.0000
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
1 ADIH001663 0.03Below limit of
Detection(LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected
Below limit of Detection
(LOD:9.6ppm)
2 ADIH001640 0.03Below limit of
detection(LOD:0.002%)
Notdetected
152 Notdetected
Below limit of detection
(LOD:33.8ppm)
Notdetected Notdetected
3 ADIH001193 0.05 Not detected Not detected
181 Not detected
Below Limit of Detection
(BLD:33.8ppm)
Not detected
Below Limit of Detection
(BLD:9.6ppm)
ANNUAL REVIEW REPORT- PRODUCT
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99Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
4 ADIH001584 0.01Below limit of
detection(LOD:0.002%)
Notdetected
149 Notdetected
Below limit of detection
(LOD:33.8ppm)
Notdetected
Below limit of detection
(LOD:9.6ppm)
5 ADIH001583 0.02Below limit of
detection (LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
6 ADIH001884 0.02 Less than LOQ (LOQ:0.008%)
Not detected
191 Not detected 276 Not detected Not detected
7 ADIH001910 0.02 Less than LOQ(LOQ:0.008%)
Not detected
151 Not detected 214 Not detected Not detected
8 ADIH001911 0.04 Less than LOQ(LOQ:0.008%)
Not detected
139 Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected
Below limit of Detection
(LOD:9.6ppm)
9 ADIH001935 0.02 Less than LOQ(LOQ: 0.008%)
Not detectedLess than
LOQ(LOQ: 135.9ppm)
Not detected
Below Limit of Detection
(LOD:33.8ppm)
Not detected Not detected
10 ADIH001936 0.02 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected Not detected Not detected Not detected
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100Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
11 ADIH001883 0.02Below limit of
detection (LOD:0.002%)
Not detected
178 Not detectedLess than LOQ (LOQ:112.5pp
m)
Not detected Not detected
12 ADIH001882 0.03 Less than LOQ (LOQ:0.008%)
Not detected
184 Not detected 107 Not detected
Below limit of detection
(LOD:9.6ppm)
13 ADIH001835 0.04 Not detected Not detected
153 Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected
Below limit of Detection
(LOD:9.6ppm)
14 ADIH001834 0.02Below limit of
detection(LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
15 ADIH001987 0.03Below limit of
detection (LOD:0.002%)
Not detected
156 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
16 ADIH001988 0.03 Less than LOQ (LOQ:0.008%)
Not detected
133 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
ANNUAL REVIEW REPORT- PRODUCT
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101Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
17 ADIH002007 0.01 Not detected
Less than LOQ
(LOQ:59.1ppm)
167 Not detected
Below limit of Detection
(LOD:10ppm)
Not detected Not detected
18 ADIH002009 0.03 Not detected
Less than LOQ
(LOQ:59.1ppm)
140 Not detected Not detected Not
detected Not detected
19 ADIH001833 0.03Below limit of
detection(LOD:0.002%)
Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected
Below limit of detection
(LOD:9.6ppm)
20 ADIH001666 0.02 Not detected Not detected
159 Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected Not detected
21 ADIH001725 0.03 Not detected Not detected
153 Not detected
Below Limit of Detection
(LOD:33.8ppm)
Not detected
Below Limit of Detection(LOD:
9.6ppm)
22 ADIH001724 0.04 Not detected Not detected
142 Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected
Below limit of Detection
(LOD:9.6ppm)
ANNUAL REVIEW REPORT- PRODUCT
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102Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
23 ADIH001419 0.07 Less than LOQ(LOQ:0.008%)
Not detected
163 Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected
Below limit of Detection
(LOD:9.6ppm)
24 ADIH001474 0.06 Less than LOQ (LOQ:0.008%)
Not detected
153 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
25 ADIH001667 0.03 Not detected Not detected
Less than LOQ
(LOQ:135.9ppm)
Not detected
Below limit of Detection
(LOD:33.8ppm)
Not detected Not detected
26 ADIH001475 0.03Below limit of
detection (LOD:0.002%)
Not detected
162 Not detected
Below limit of detection
(LOD:33.8 ppm)
Not detected Not detected
27 ADIH001579 Less than LOQ(LOQ:0.008%)
Not detected Not detected
141 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
28 ADIH001580 Less than LOQ(LOQ:0.008%)
Not detected Not detected
138 Not detectedLess than LOQ(LOQ:112.5pp
m)
Not detected Not detected
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103Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Related Substances by HPLC (Method-2) ( Limit: NMT 0.1 % )
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC: Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Isopropyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
29 ADIH001581 0.03 Not detected Not detected
200 Not detected
Below limit of detection
(LOD:33.8ppm)
Not detected Not detected
30 ADIH001582 0.03 Not detected Not detected
162 Not detected Not detected Not detected Not detected
MEAN-BY SYSTEM 0.0280 0.0000 0.0000 121.5667 0.0000 19.9000 0.0000 0.0000
SIGMA-BY SYSTEM 0.0141 0.0000 0.0000 69.9811 0.0000 64.7384 0.0000 0.0000
+3 SIGMA-BY SYSTEM
0.0703 0.0000 0.0000 331.5100 0.0000 214.1152 0.0000 0.0000
-3 SIGMA-BY SYSTEM
-0.0143 0.0000 0.0000 -88.3766 0.0000 -174.3152 0.0000 0.0000
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104Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
1 ADIH001663 Not detected Not detected Not detected Complies 100 100
100 0.58
2 ADIH001640 177 Notdetected Notdetected Complies 100 100
100 0.56
3 ADIH001193Below Limit of
Detection(BLD:44.4ppm)
Not detected Not detected Complies 100 100
99 0.55
4 ADIH001584 174 Notdetected Notdetected Complies 100 100
98 0.63
5 ADIH001583 174 Not detected Not detected Complies 100 100
99 0.59
6 ADIH001884 186 Not detected Not detected Complies 100 100
100 0.55
7 ADIH001910 155 Not detected Not detected Complies 100 100
100 0.54
8 ADIH001911 Not detected Not detected Not detected Complies 100 100
100 0.54
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105Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
9 ADIH001935 Not detected Not detected Not detected Complies 100 100
100 0.55
10 ADIH001936Below limit of
Detection(LOD:44.4ppm)
Not detected Not detected Complies 100 100
100 0.59
11 ADIH001883 225 Not detected Not detected Complies 100 100
99 0.58
12 ADIH001882 239 Not detected Not detected Complies 100 100
98 0.57
13 ADIH001835 Not detected Not detected Not detected Complies 100 100
100 0.57
14 ADIH001834Below limit of
detection(LOD:44.4ppm)
Not detected Not detected Complies 100 100
100 0.56
15 ADIH001987Below limit of
detection (LOD:44.4ppm)
Not detected Not detected Complies 100 100
100 0.54
16 ADIH001988Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.60
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106Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
17 ADIH002007 Not detected Not detected
Below limit of Detection
(LOD:100ppm)
Complies 100 100
100 0.52
18 ADIH002009Below limit of
Detection(LOD:44.4ppm)
Not detected Not detected Complies 100 100
100 0.60
19 ADIH001833Below limit of
detection(LOD:44.4ppm)
Not detected Not detected Complies 100 100
100 0.56
20 ADIH001666 Not detected Not detected
462 Complies 100 100
100 0.58
21 ADIH001725 Not detected Not detected Not detected Complies 100 100
100 0.60
22 ADIH001724 Not detected Not detected Not detected Complies 100 100
100 0.64
23 ADIH001419 Not detected Not detected Not detected Complies 100 100
98 0.61
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107Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Dimethyl ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
XRD ( LIMIT: The 2-Theta values at ~8.9, ~12.9, ~18.4, ~21.0 and ~21.8 in the sample diffractogram should match with tha
*Particle size by Laser diffraction (Limit: NLT 100.0 % )
*Particle size by Laser diffraction (Limit: NLT 90.0 % )
*Particle size by Laser diffraction (Limit: NLT 50.0 % )
*Tapped density ( LIMIT:)
24 ADIH001474Less than LOQ (LOQ:147.7pp
m)Not detected Not detected Complies 100 100
100 0.59
25 ADIH001667 Not detected Not detected
Less than LOQ
(LOQ:370ppm)
Complies 100 100
100 0.59
26 ADIH001475Less than LOQ(LOQ: 147.7
ppm)Not detected Not detected Complies 100 100
100 0.57
27 ADIH001579 Not detected Not detected Not detected Complies 100 100
100 0.60
28 ADIH001580 Not detected Not detected Not detected Complies 100 100
100 0.59
29 ADIH001581 Not detected Not detected Not detected Complies 100 100
100 0.59
30 ADIH001582 Not detected Not detected Not detected Complies 100 100
99 0.58
MEAN-BY SYSTEM 44.3333 0.0000 15.4000 NA 100.0000 100.0000 99.6667 0.5773
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
SIGMA-BY SYSTEM 82.8968 0.0000 84.3493 NA 0.0000 0.0000 0.6609 0.0265
+3 SIGMA-BY SYSTEM
293.0237 0.0000 268.4479 NA 100.0000 100.0000 101.6494 0.6568
-3 SIGMA-BY SYSTEM
-204.3571 0.0000 -237.6479 NA 100.0000 100.0000 97.6840 0.4978
QA FINAL COMMENTS
Total no. of batches analyzed during the review period: 30 No. ofbatches approved during the review period: 30 No. of batches rejectedduring this review period: 0 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 50.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 90.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Tapped density (LIMIT:):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Assay byHPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,
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109Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Melting Point(Limit: Between188.0 and 194.0 °C):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC ( Limit: NMT 0.2 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC (Method-1) ( Limit: NMT 0.1 %):ADIH001724,ADIH001911 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:55:22 Ok reviewed ModifiedBy : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015at 21:55:22 reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 05/10/2015 at 22:37:54 Ok Reviewed Modified By : HP- Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:52:10 sss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:10:17 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:17:47 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:33:48 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :
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Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
21/10/2015 at20:29:49 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:37:32 SSS Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:32:18ast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:34:11
19.1.3 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Quality Trend of
S-08-OI/14Specification Ref. No.
20.00Scale
NOT APPLICABLEValidation Form No.
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
1 ADIH000198Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.03Less than 10
ppm 191.8
2 ADIH000225Yellow colour
crystalline powder.
Complies Complies
0.2 0.09
0.02Less than 10
ppm 192.1
3 ADIH000226Yellow colour
crystalline powder.
Complies Complies
0.2 0.08
0.03Less than 10
ppm 190.2
4 ADIH000227Yellow colour
crystalline powder.
Complies Complies
0.2 0.05
0.01Less than 10
ppm 191.2
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111Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
5 ADIH000271Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.02Less than 10
ppm 191.2
6 ADIH000272Yellow colour
crystalline powder.
Complies Complies
0.3 0.07
0.02Less than 10
ppm 190.9
7 ADIH000285Yellow colour
crystalline powder.
Complies Complies
0.3 0.06
0.03Less than 10
ppm 192.0
8 ADIH000286Yellow colour
crystalline powder.
Complies Complies
0.3 0.08
0.03Less than 10
ppm 191.9
9 ADIH000354Yellow colour
crystalline powder.
Complies Complies
0.2 0.09
0.02Less than 10
ppm 192.1
10 ADIH000355Yellow colour
crystalline powder.
Complies Complies
0.2 0.05
0.01Less than 10
ppm 191.9
11 ADIH000375Yellow colour
crystalline powder.
Complies Complies
0.3 0.08
0.03Less than 10
ppm 191.9
12 ADIH000376Yellow colour
crystalline powder.
Complies Complies
0.2 0.07
0.03Less than 10
ppm 190.6
13 ADIH000171Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.03Less than 10
ppm 191.5
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112Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
14 ADHH003943Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.01Less than 10
ppm 191.8
15 ADHH003989Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.01Less than 10
ppm 191.2
16 ADHH004012Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.01Less than 10
ppm 191.8
17 ADHH004013Yellow colour
crystalline powder.
Complies Complies
0.2 0.3
0.02Less than 10
ppm 191.7
18 ADHH004014Yellow colour
crystalline powder.
Complies Complies
0.2 0.08
0.02Less than 10
ppm 190.9
19 ADHH004015Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.02Less than 10
ppm 191.9
20 ADHH004016Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.7
21 ADHH004041Yellow colour
crystalline powder.
Complies Complies
0.2 0.3
0.01Less than 10
ppm 190.2
22 ADHH004061Yellow colour
crystalline powder.
Complies Complies
0.2 0.0
0.02Less than 10
ppm 190.8
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113Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
23 ADHH004062Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.7
24 ADIH000038Yellow colour
crystalline powder.
Complies Complies
0.2 0.07
0.02Less than 10
ppm 190.5
25 ADIH000039Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 191.2
26 ADIH000051Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.04Less than 10
ppm 191.9
27 ADIH000170Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.01Less than 10
ppm 192.9
28 ADIH000197Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.01Less than 10
ppm 191.5
29 ADIH001958Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.04Less than 10
ppm 192.1
30 ADIH001959Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.04Less than 10
ppm 191.2
31 ADIH001960Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.01Less than 10
ppm 191.2
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114Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
32 ADIH001962Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.01Less than 10
ppm 189.9
33 ADIH001664Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.02Less than 10
ppm 192.4
34 ADIH001371Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 192.9
35 ADIH001372Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.01Less than 10
ppm 189.9
36 ADIH001333Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 190.0
37 ADIH001359Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.4
38 ADIH001404Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.0
39 ADIH001418Yellow colour
crystalline powder.
Complies Complies
0.3 0.06
0.02Less than 10
ppm 190.1
40 ADIH001639Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.01Less than 10
ppm 192.3
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115Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
41 ADIH000902Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 190.8
42 ADHH003544Yellow colour
crystalline powder.
Complies Complies
0.3 0.3
0.01Less than 10
ppm 191.2
43 ADHH003571Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.04Less than 10
ppm 190.1
44 ADHH003586Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.03Less than 10
ppm 189.9
45 ADIH000890Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.0
46 ADIH000874Yellow colour
crystalline powder.
Complies Complies
0.3 0.2
0.03Less than 10
ppm 190.2
47 ADHH003613Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.6
48 ADHH003614Yellow colour
crystalline powder.
Complies Complies
0.1 0.3
0.01Less than 10
ppm 190.5
49 ADIH000818Yellow colour
crystalline powder.
Complies Complies
0.1 0.09
0.02Less than 10
ppm 189.5
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116Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
50 ADHH003667Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.02Less than 10
ppm 193.2
51 ADHH003688Yellow colour
crystalline powder.
Complies Complies
0.3 0.2
0.02Less than 10
ppm 189.9
52 ADIH000643Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 191.7
53 ADIH000642Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 190.2
54 ADHH003543Yellow colour
crystalline powder.
Complies Complies
0.3 0.3
0.02Less than 10
ppm 190.2
55 ADHH002993Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 191.2
56 ADHH003012Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.9
57 ADHH003021Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.02Less than 10
ppm 191.1
58 ADHH003060Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.02Less than 10
ppm 191.1
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117Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
59 ADHH003086Yellow colour
crystalline powder.
Complies Complies
0.2 0.3
0.01Less than 10
ppm 191.4
60 ADHH003101Yellow colour
crystalline powder.
Complies Complies
0.2 0.09
0.01Less than 10
ppm 189.9
61 ADHH003102Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 190.7
62 ADHH003108Yellow colour
crystalline powder.
Complies Complies
0.1 0.09
0.02Less than 10
ppm 191.7
63 ADHH003228Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.02Less than 10
ppm 191.5
64 ADHH003239Yellow colour
crystalline powder.
Complies Complies
0.3 0.2
0.02Less than 10
ppm 189.9
65 ADHH003270Yellow colour
crystalline powder.
Complies Complies
0.2 0.2
0.03Less than 10
ppm 190.8
66 ADHH003305Yellow colour
crystalline powder.
Complies Complies
0.2 0.1
0.01Less than 10
ppm 191.9
67 ADIH001273Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.02Less than 10
ppm 189.9
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118Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Description ( LIMIT: Pale yellow to yellow colour crystalline Powder.)
Solubility ( LIMIT: Freely soluble in chloroform)
Identification by IR ( LIMIT: To match with working standard)
Loss on drying ( Limit: NMT 0.5 %w/w )
Moisture Content ( Limit: NMT 0.5 %w/w )
Residue on ignition ( Limit: NMT 0.1 %w/w )
Heavy metals ( LIMIT: Not more than 10 ppm)
Melting point( Limit: Between188.0 and 194.0 °C )
68 ADIH001272Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.02Less than 10
ppm 191.9
69 ADIH001271Yellow colour
crystalline powder.
Complies Complies
0.3 0.2
0.01Less than 10
ppm 191.2
70 ADIH001270Yellow colour
crystalline powder.
Complies Complies
0.3 0.2
0.02Less than 10
ppm 190.8
71 ADIH000172Yellow colour
crystalline powder.
Complies Complies
0.3 0.1
0.03Less than 10
ppm 191.6
MEAN-BY SYSTEM NA NA NA 0.2254 0.1451 0.0208 NA 191.1817
SIGMA-BY SYSTEM NA NA NA 0.0529 0.0728 0.0100 NA 0.8323
+3 SIGMA-BY SYSTEM NA NA NA 0.3841 0.3635 0.0508 NA 193.6786
-3 SIGMA-BY SYSTEM NA NA NA 0.0667 -0.0733 -0.0092 NA 188.6848
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119Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
1 ADIH000198 Not detected 0.01 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.06
2 ADIH000225 Not detected 0.04 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.06
3 ADIH000226 Not detected 0.04 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.07
4 ADIH000227 Not detected Less than LOQ(LOQ:0.012%)
Not detected Not detected Not detected Not detected Not detected 0.07
5 ADIH000271 Not detected 0.02 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.07
6 ADIH000272 Not detected 0.02 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.07
7 ADIH000285 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.07
8 ADIH000286 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.07
9 ADIH000354 Not detected 0.01 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.08
10 ADIH000355 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
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120Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
11 ADIH000375 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
12 ADIH000376 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.09
13 ADIH000171 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
14 ADHH003943 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
15 ADHH003989 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.10
16 ADHH004012 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
17 ADHH004013 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.08
18 ADHH004014 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.09
19 ADHH004015 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.07
20 ADHH004016 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.08
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121Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
21 ADHH004041 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
22 ADHH004061 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.09
23 ADHH004062 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.09
24 ADIH000038 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.09
25 ADIH000039 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.10
26 ADIH000051 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
27 ADIH000170 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.08
28 ADIH000197 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.06
29 ADIH001958 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.08
30 ADIH001959 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
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122Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
31 ADIH001960 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.10
32 ADIH001962 Not detected 0.02 Not detected Not detected Not detected Not detected Not detected 0.08
33 ADIH001664 Not detected Not detected Not detected Not detected Not detected Not detected Not detected 0.08
34 ADIH001371 Not detected Less than LOQ(LOQ:0.012%)
Not detected Not detectedBelow limit of
detection(LOD:0.020%)
Not detected Not detected 0.09
35 ADIH001372 Not detected Less than LOQ(LOQ:0.012%)
Not detected Not detectedBelow limit of
detection(LOD:0.0054%)
Not detected Not detected 0.06
36 ADIH001333 Not detected 0.05 Not detected Not detectedBelow limit of
detection(LOD:0.0054%)
Not detected Not detected 0.08
37 ADIH001359 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.07
38 ADIH001404 Not detected 0.01 Not detected Not detectedBelow limit of
detection(LOD:0.0054%)
Not detected Not detected 0.07
39 ADIH001418 Not detected Less than LOQ(LOQ: 0.012%)
Not detected Not detectedBelow Limit of Detection(LOD:
0.0054%)Not detected
Less than LOQ(LOQ: 0.0404%)
0.05
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123Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
40 ADIH001639 Not detected Not detected Not detected Not detected Not detected Not detected Not detected 0.07
41 ADIH000902 Not detected 0.02 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.07
42 ADHH003544 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
43 ADHH003571 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.08
44 ADHH003586 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
45 ADIH000890 Not detected 0.04 Not detected Not detectedBelow limit of
Detection(LOD:0.0054%)
Not detected Not detected 0.06
46 ADIH000874 Not detected 0.04 Not detected Not detectedBelow limit of
Detection(LOD:0.0054%)
Not detected Not detected 0.06
47 ADHH003613 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.09
48 ADHH003614 Not detected 0.08 Not detected Not detected Not detected Not detected Not detected 0.09
49 ADIH000818 Not detected 0.07 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.08
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124Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
50 ADHH003667 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.11
51 ADHH003688 Not detected 0.07 Not detected Not detected Not detected Not detected Not detected 0.08
52 ADIH000643 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.10
53 ADIH000642 Not detected 0.08 Not detected Not detected Not detected Not detected Not detected 0.10
54 ADHH003543 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.08
55 ADHH002993 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.07
56 ADHH003012 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.07
57 ADHH003021 Not detected 0.07 Not detected Not detected Not detected Not detected Not detected 0.06
58 ADHH003060 Not detected 0.06 Not detected Not detected Not detected Not detected Not detected 0.07
59 ADHH003086 Not detected 0.11 Not detected Not detected Not detected Not detected Not detected 0.09
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125Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
60 ADHH003101 Not detected 0.07 Not detected Not detected Not detected Not detected Not detected 0.09
61 ADHH003102 Not detected 0.07 Not detected Not detected Not detected Not detected Not detected 0.09
62 ADHH003108 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.09
63 ADHH003228 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.09
64 ADHH003239 Not detected 0.10 Not detected Not detected Not detected Not detected Not detected 0.08
65 ADHH003270 Not detected 0.03 Not detected Not detected Not detected Not detected Not detected 0.07
66 ADHH003305 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.07
67 ADIH001273 Not detected 0.04 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.10
68 ADIH001272 Not detected 0.07 Not detected Not detectedBelow limit of
detection (LOD:0.0054%)
Not detected Not detected 0.08
69 ADIH001271 Not detected 0.05 Not detected Not detected Not detected Not detected Not detected 0.09
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126Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : PIN 3 ( Limit: NMT 0.1 % )
Related Substances by HPLC : NOR PIN ( Limit: NMT 0.2 % )
Related Substances by HPLC : PIN Deg. ( Limit: NMT 0.1 % )
Related Substances by HPLC : PIN-3(H) ( Limit: NMT 0.1 % )
Related Substances by HPLC : N-Oxide ( Limit: NMT 0.2 % )
Related Substances by HPLC : LIP-1 acetyl ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-1 dimer ( Limit: NMT 0.1 % )
Related Substances by HPLC : LIP-2 quarternary salt ( Limit: NMT 0.2 % )
70 ADIH001270 Not detected 0.05 Not detected Not detected Less than LOQ(LOQ:0.020%)
Not detected Not detected 0.14
71 ADIH000172 Not detected 0.04 Not detected Not detected Not detected Not detected Not detected 0.09
MEAN-BY SYSTEM 0.0000 0.0445 0.0000 0.0000 0.0000 0.0000 0.0000 0.0804
SIGMA-BY SYSTEM 0.0000 0.0224 0.0000 0.0000 0.0000 0.0000 0.0000 0.0141
+3 SIGMA-BY SYSTEM
0.0000 0.1117 0.0000 0.0000 0.0000 0.0000 0.0000 0.1227
-3 SIGMA-BY SYSTEM
0.0000 -0.0227 0.0000 0.0000 0.0000 0.0000 0.0000 0.0381
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
1 ADIH000198 0.01 0.09
99.9 Complies Not detected 153 Not detected Not detected
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127Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
2 ADIH000225 0.01 0.12
98.8 Complies Not detected 164 Not detected Not detected
3 ADIH000226 0.01 0.14
99.2 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
4 ADIH000227 0.01 0.09
99.0 Complies Not detected 145 Not detected Not detected
5 ADIH000271 0.02 0.12
99.3Does not comply Not detected 152 Not
detected
Below limit of detection
(LOD:33.8ppm)
6 ADIH000272 0.01 0.11
99.7 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
7 ADIH000285 0.01 0.13
99.2 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
8 ADIH000286 0.01 0.12
99.6 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
9 ADIH000354 0.01 0.13
99.7 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
10 ADIH000355 0.01 0.15
100.2 Complies Not detected 153 Not detected Not detected
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128Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
11 ADIH000375 0.01 0.14
100.5 Complies Not detected 140 Not detected Not detected
12 ADIH000376 0.01 0.14
100.0 Complies Not detected 137 Not detected Not detected
13 ADIH000171 0.01 0.14
99.5 Complies Not detected 209 Not detected Not detected
14 ADHH003943 0.01 0.14
99.6 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
15 ADHH003989 0.01 0.16
99.9 Complies Not detected 142 Not detected Not detected
16 ADHH004012 0.01 0.14
99.8 Complies Not detected 178 Not detected Not detected
17 ADHH004013 0.01 0.13
99.9 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
18 ADHH004014 0.01 0.14
100.3 Complies Not detected 152 Not detected Not detected
19 ADHH004015 0.01 0.13
99.9 Complies Not detected 157 Not detected Not detected
20 ADHH004016 0.01 0.13
99.4 Complies Not detected 137 Not detected Not detected
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129Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
21 ADHH004041 0.01 0.14
99.8 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
22 ADHH004061 Not detected 0.15
100.2 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
23 ADHH004062 Not detected 0.14
99.4 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
24 ADIH000038 Not detected 0.13
99.2 Complies Not detected 179 Not detected Not detected
25 ADIH000039 Not detected 0.15
98.5 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
26 ADIH000051 Not detected 0.13
99.6 Complies Not detected 142 Not detected Not detected
27 ADIH000170 0.02 0.15
98.7 Complies Not detected 121 Not detected Not detected
28 ADIH000197 0.02 0.12
99.5 Complies Not detected 141 Not detected Not detected
29 ADIH001958 0.01 0.15
100.2 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
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130Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
30 ADIH001959 0.01 0.14
100.0 Complies Not detected 138 Not detected
Below limit of Detection
(LOD:33.8ppm)
31 ADIH001960 0.01 0.15
100.4 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
32 ADIH001962 Not detected 0.11
99.9 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
33 ADIH001664 0.01 0.09
100.2 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected
Less than LOQ(LOQ:112.5ppm
)
34 ADIH001371 Not detected 0.11
100.0 Complies Not detected 177
Below limit of
detection(LOD:40.3
ppm)
Below limit of detection
(LOD:33.8ppm)
35 ADIH001372 Not detected 0.08
100.0 Complies Not detected 182
Below limit of
detection(LOD:40.3
ppm)
Below limit of detection
(LOD:33.8ppm)
36 ADIH001333 Not detected 0.13
99.7 Complies Not detected 161 Not detected
Below limit of detection
(LOD:33.8ppm)
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131Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
37 ADIH001359 Not detected 0.12
99.8 Complies Not detectedLess than LOQ
(LOQ: 135.9ppm)
Not detected Not detected
38 ADIH001404 Not detected 0.08
99.8 Complies Not detected 170
Below limit of
detection(LOD:40.3
ppm)
Not detected
39 ADIH001418 0.002 0.08
100.6 Complies Not detected 227 Not detected
Below Limit of Detection
(LOD:33.8ppm)
40 ADIH001639 0.01 0.08
100.0 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected
Below limit of detection
(LOD:33.8ppm)
41 ADIH000902 Not detected 0.10
99.6 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected
Below limit of Detection
(LOD:33.8ppm)
42 ADHH003544 0.01 0.14
99.8 Complies Not detected 140 Not detected Not detected
43 ADHH003571 0.01 0.13
100.1 Complies Not detected 162 Not detected Not detected
44 ADHH003586 0.01 0.14
100 Complies Not detected 143 Not detected Not detected
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132Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
45 ADIH000890 Not detected 0.10
99.8 Complies Not detected 171 Not detected
Below limit of Detection
(LOD:33.8ppm)
46 ADIH000874 Not detected 0.10
99.8 Complies Not detected 192 Not detected
Below limit of Detection
(LOD:33.8ppm)
47 ADHH003613 0.01 0.17
99.1 Complies Not detected 140 Not detected Not detected
48 ADHH003614 0.01 0.19
99.3 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
49 ADIH000818 Not detected 0.16
99.5 Complies Not detected 160 Not detected
Below limit of Detection
(LOD:33.8ppm)
50 ADHH003667 0.02 0.16
99.6 Complies Not detected 140 Not detected Not detected
51 ADHH003688 0.01 0.16
99.6 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
52 ADIH000643 0.01 0.17
100.2 Complies Not detected 137 Not detected Not detected
53 ADIH000642 0.01 0.18
99.9 Complies Not detected 155 Not detected Not detected
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133Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
54 ADHH003543 Not detected 0.13
99.7 Complies Not detected 156 Not detected Not detected
55 ADHH002993 Not detected 0.12
99.5 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
56 ADHH003012 Not detected 0.13
99.7 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
57 ADHH003021 Not detected 0.13
99.8 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
58 ADHH003060 Not detected 0.13
99.7 Complies Not detectedLess than LOQ (LOQ:135.9pp
m)
Not detected Not detected
59 ADHH003086 Not detected 0.20
99.1 Complies Not detected 148 Not detected Not detected
60 ADHH003101 Not detected 0.15
99.8 Complies Not detected 152 Not detected Not detected
61 ADHH003102 Not detected 0.16
99.3 Complies Not detected 181 Not detected Not detected
62 ADHH003108 Not detected 0.13
99.8 Complies Not detected 179 Not detected
Less than LOQ (LOQ:112.5ppm
)
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134Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Related Substances by HPLC : Any other Impurity ( Limit: NMT 0.1 % )
Related Substances by HPLC : Total Impurities ( Limit: NMT 0.5 % )
Assay by HPLC (On dried basis)( Limit: Between98.0 and 102.0 %w/w )
XRD ( LIMIT: To match with working standard)
Residual Solvents by GC : Chloroform ( Limit: NMT 60.0 ppm )
Residual Solvents by GC:Dichloromethane ( Limit: NMT 600.0 ppm )
Residual Solvents by GC: 1,4 Dioxane ( Limit: NMT 200.0 ppm )
Residual Solvents by GC : Methanol ( Limit: NMT 3000.0 ppm )
63 ADHH003228 Not detected 0.14
99.5 Complies Not detected 180 Not detected Not detected
64 ADHH003239 Not detected 0.18
99.5 Complies Not detected 166 Not detected Not detected
65 ADHH003270 Not detected 0.10
99.5 Complies Not detected 157 Not detected Not detected
66 ADHH003305 Not detected 0.11
100.0 Complies Not detected 137 Not detected Not detected
67 ADIH001273 Not detected 0.15
100.1 Complies Not detected 137
Below limit of
detection(LOD:40.3
ppm)
Not detected
68 ADIH001272 Not detected 0.16
99.5 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected Not detected
69 ADIH001271 Not detected 0.15
100.2 Complies Not detected 178 Not detected
Below limit of detection
(LOD:33.8ppm)
70 ADIH001270 Not detected 0.20
99.8 Complies Not detectedLess than LOQ(LOQ:135.9pp
m)
Not detected
Below limit of detection
(LOD:33.8ppm)
71 ADIH000172 0.01 0.14
99.3 Complies Not detected 173 Not detected Not detected
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135Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
MEAN-BY SYSTEM 0.0059 0.1342 99.7042 NA 0.0000 100.5775 0.0000 0.0000
SIGMA-BY SYSTEM 0.0000 0.0265 0.4055 NA 0.0000 78.7861 0.0000 0.0000
+3 SIGMA-BY SYSTEM
0.0059 0.2137 100.9207 NA 0.0000 336.9358 0.0000 0.0000
-3 SIGMA-BY SYSTEM
0.0059 0.0547 98.4877 NA 0.0000 -135.7808 0.0000 0.0000
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
1 ADIH000198 Not detected Not detected
808 Not detected Not detected 100
100 97
2 ADIH000225 Not detected Not detected Not detected Not detected Not detected 100
100 100
3 ADIH000226 Not detected Not detected Not detected Not detected Not detected 100
100 100
4 ADIH000227 Not detected Not detected Not detected Not detected Not detected 100
100 100
5 ADIH000271 Not detected Not detected
659 Not detectedBelow limit of
detection(LOD:100ppm)
100
100 100
6 ADIH000272 Not detected Not detected
309 Not detected Not detected 100
100 100
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136Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
7 ADIH000285 Not detected Not detected
700 Not detected Not detected 100
100 100
8 ADIH000286 Not detected Not detected
348 Not detected Not detected 100
100 100
9 ADIH000354 Not detected Not detected Not detected Not detected Not detected 100
100 100
10 ADIH000355 Not detected Not detected Not detected Not detected Not detected 100
100 100
11 ADIH000375 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
12 ADIH000376 Not detected Not detected Not detected Not detected Not detected 100
100 100
13 ADIH000171 Not detected Not detected Not detected Not detected Not detected 100
100 100
14 ADHH003943 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
15 ADHH003989 Not detected Not detected
152 Not detected Not detected 100
100 100
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137Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
16 ADHH004012 Not detected Not detected
154 Not detected Not detected 100
100 100
17 ADHH004013 Not detected Not detected Not detected Not detected Not detected 100
100 100
18 ADHH004014 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
19 ADHH004015 Not detected Not detected
590 Not detected Not detected 100
100 100
20 ADHH004016 Not detected Not detected
238 Not detected Not detected 100
100 99
21 ADHH004041 Not detected Not detected Not detected Not detected Not detected 100
100 100
22 ADHH004061 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
23 ADHH004062 Not detected Not detected Not detected Not detected Not detected 100
100 100
24 ADIH000038 Not detected Not detected
404 Not detected Not detected 100
100 100
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138Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
25 ADIH000039 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
26 ADIH000051 Not detected Not detected
182 Not detected Not detected 100
100 100
27 ADIH000170 Not detected Not detected Not detected Not detected Not detected 100
100 100
28 ADIH000197 Not detected Not detected
196 Not detected Not detected 100
100 100
29 ADIH001958 Not detected Not detected
Below limit of detection
(LOD:44.4ppm)
Not detected Not detected 100
100 100
30 ADIH001959 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
31 ADIH001960 Not detected Not detected
Below limit of detection
(LOD:44.4ppm)
Not detected Not detected 100
100 100
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139Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
32 ADIH001962 Not detected Not detected
Below limit of Detection
(LOD:44.4ppm)
Not detected Not detected 100
100 100
33 ADIH001664 Not detectedBelow limit of
detection(LOD:9.6ppm)
Not detected Not detected Not detected 100
100 98
34 ADIH001371 Not detectedBelow limit of
detection(LOD:9.6ppm)
Not detected Not detected Not detected 99
99 94
35 ADIH001372 Not detectedBelow limit of
detection(LOD:9.6ppm)
Not detected Not detected Not detected 100
100 94
36 ADIH001333 Not detectedBelow limit of
detection(LOD:9.6ppm)
482 Not detected Not detected 100
100 99
37 ADIH001359 Not detectedBelow Limit of Detection(LOD:
9.6ppm)
Below Limit of Detection
(LOD: 44.4ppm)
Not detected Not detected 100
100 100
38 ADIH001404 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 97
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140Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
39 ADIH001418 Not detectedBelow Limit of Detection(LOD:
9.6ppm)Not detected Not detected Not detected 100
100 100
40 ADIH001639 Not detected Not detected
180 Not detected Not detected 100
100 99
41 ADIH000902 Not detected Not detected Not detected Not detected Not detected 100
100 100
42 ADHH003544 Not detected Not detected Not detected Not detected Not detected 100
100 100
43 ADHH003571 Not detected Not detected Not detected Not detected Not detected 100
100 100
44 ADHH003586 Not detected Not detected Not detected Not detected Not detected 100
100 100
45 ADIH000890 Not detected Not detected Not detected Not detected Not detected 100
100 100
46 ADIH000874 Not detected Not detected Not detected Not detected Not detected 100
100 100
47 ADHH003613 Not detected Not detected Not detected Not detected Not detected 100
100 100
48 ADHH003614 Not detected Not detected Not detected Not detected Not detected 100
100 100
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141Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
49 ADIH000818 Not detected Not detected Not detected Not detected Not detected 100
100 100
50 ADHH003667 Not detected Not detected
211 Not detected Not detected 100
100 100
51 ADHH003688 Not detected Not detected Not detected Not detected Not detected 100
100 100
52 ADIH000643 Not detected Not detected Not detected Not detected Not detected 100
100 100
53 ADIH000642 Not detected Not detected
325 Not detected Not detected 100
100 99
54 ADHH003543 Not detected Not detected Not detected Not detected Not detected 100
100 100
55 ADHH002993 Not detected Not detected Not detected Not detected Not detected 100
100 99
56 ADHH003012 Not detected Not detected Not detected Not detected Not detected 100
100 100
57 ADHH003021 Not detected Not detected Not detected Not detected Not detected 100
100 100
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142Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
58 ADHH003060 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 99
59 ADHH003086 Not detected Not detected Not detected Not detected Not detected 100
100 100
60 ADHH003101 Not detected Not detected Not detected Not detected Not detected 100
100 100
61 ADHH003102 Not detected Not detected Not detected Not detected Not detected 100
100 99
62 ADHH003108 Not detected Not detected
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 99
63 ADHH003228 Not detected Not detected
478 Not detected Not detected 100
100 100
64 ADHH003239 Not detected Not detected Not detected Not detected Not detected 100
100 100
65 ADHH003270 Not detected Less than LOQ (LOQ:32.1ppm)
Not detected Not detected Not detected 100
100 100
66 ADHH003305 Not detected Less than LOQ (LOQ:32.1ppm)
Not detected Not detected Not detected 100
100 100
ANNUAL REVIEW REPORT- PRODUCT
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143Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
S.No. Batch No.
Residual Solvents by GC : Isopropyl alcohol ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Toluene ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Dimethyl sulphoxide ( Limit: NMT 3000.0 ppm )
Residual Solvents by GC : Dimethyl formamide ( Limit: NMT 600.0 ppm )
Residual Solvents by GC : Acetic acid ( Limit: NMT 3000.0 ppm )
**Particle size by Laser diffraction (Limit: NLT 100.0 % )
**Particle size by Laser diffraction (Limit: NLT 90.0 % )
**Particle size by Laser diffraction (Limit: NLT 50.0 % )
67 ADIH001273 Not detected Not detected
Below limit of detection
(LOD:44.4ppm)
Not detected Not detected 100
100 97
68 ADIH001272 Not detected Not detected
Below limit of Detection
(LOD:44.4ppm)
Not detected Not detected 100
100 99
69 ADIH001271 Not detectedBelow limit of
detection(LOD:9.6ppm)
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 100
70 ADIH001270 Not detectedBelow limit of
detection (LOD:9.6ppm)
Less than LOQ
(LOQ:147.7ppm)
Not detected Not detected 100
100 87
71 ADIH000172 Not detected Not detected Not detected Not detected Not detected 100
100 100
MEAN-BY SYSTEM 0.0000 0.0000 90.3662 0.0000 0.0000 99.9859 99.9859 99.3662
SIGMA-BY SYSTEM 0.0000 0.0000 190.6236 0.0000 0.0000 0.1187 0.1187 1.8992
+3 SIGMA-BY SYSTEM
0.0000 0.0000 662.2370 0.0000 0.0000 100.3420 100.3420 105.0638
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144Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
-3 SIGMA-BY SYSTEM
0.0000 0.0000 -481.5046 0.0000 0.0000 99.6298 99.6298 93.6686
QA FINAL COMMENTS
Total no. of batches analyzed during the review period: 71 No. ofbatches approved during the review period: 69 No. of batches rejectedduring this review period: 2 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: **Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 50.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 90.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,
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145Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Assay by HPLC (On dried basis)( Limit: Between98.0 and102.0 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Loss on drying ( Limit: NMT 0.5 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Melting point( Limit: Between188.0 and 194.0 °C):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Related Substances by HPLC : Any other Impurity ( Limit:NMT 0.1 %):ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960 Related Substances by HPLC : LIP-2 quarternary salt (Limit: NMT 0.2 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,
ANNUAL REVIEW REPORT- PRODUCT
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146Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:58:43 Reviewed Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at21:58:43 reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 05/10/2015 at 22:40:21 Ok Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:55:52 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 12/10/2015 at 14:56:10 ss Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at23:24:07 ss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:25:12 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:20:16 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:39:17 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On :
ANNUAL REVIEW REPORT- PRODUCT
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147Page 172of
Name of Product : LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.: PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
21/10/2015 at20:33:24 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 20:34:26 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at23:41:01SSSS PANDUast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:45:59
ANNUAL REVIEW REPORT-PRODUCT
Name of Product :
ARR No.: Reviewed Period:
This document is electronically generated.
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LIP-3 (OLANZAPINE CANADIAN MKT)
October-2014 to October-2015PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
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20.0 REVIEW OF YIELD TRENDS OF API (FINISHED) STAGES OF PRODUCT:
20.1.1 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Product Stage Code
BPR Ref.No. (Current Version):
S.No. Batch No.
Yield Results
1 ADIH002009 9.300
2 ADIH002007 9.600
Average 9.45
Standard Deviation 0.21
+3 Sigma limit 10.08
-3 Sigma limit 8.82
Details of Yield deviation batches:
S.No. Batch No. Incident No. Date of Incident Description of the Incident
Status of the Incident
InvestigationBatch Status
NA NA NA NA NA NA NA
QA FINAL COMMENTS:
ANNUAL REVIEW REPORT-PRODUCT
Name of Product :
ARR No.: Reviewed Period:
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October-2014 to October-2015PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
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Total no. of batches manufactured during the review period:002 No. of batches failed to meet the Yield limits:002 No. of batches falling outside +3 Sigma:002 No. of batches falling outside -3 Sigma:000 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:41 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:16 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:31 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:42:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:01
20.1.2 200001445-LIP-3 (OLANZAPINE CANADIAN MKT)Product Stage Code
NOTAPPLICABLEBPR Ref.No. (Current Version):
S.No. Batch No.
Yield Results
ANNUAL REVIEW REPORT-PRODUCT
Name of Product :
ARR No.: Reviewed Period:
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LIP-3 (OLANZAPINE CANADIAN MKT)
October-2014 to October-2015PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
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S.No. Batch No.
Yield Results
Average 8.90
Standard Deviation 0.59
+3 Sigma limit 10.67
-3 Sigma limit 7.13
Details of Yield deviation batches:
S.No. Batch No. Incident No. Date of Incident Description of the Incident
Status of the Incident
InvestigationBatch Status
NA NA NA NA NA NA NA
QA FINAL COMMENTS:
ANNUAL REVIEW REPORT- PRODUCT
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151Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
21.0 REVIEW OF LAST ARR
Date of Approval of Last Year's ARR:
Recommended Actionable Points from Last Year's ARR:
Status of CAPAs
S.No. Proposed CAPA Date of Completion of CAPA Status
NA NA NA NA
QA Final Comments
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:25 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:47:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:48:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:26:43 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:46:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:38
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
REVIEW OF INCIDENTS
Total no. of incidents reported during this review period: 20 No. of incidents closed: 19 No. of incidenets open: 0 No. of incidents of previous rev period closed in this rev period: 0 No. of incidents of previous rev period still open in this rev period: 0 Total no. of CAPAs raised during the review period: 0 No. of CAPAs closed: 0 No. of CAPAs open: 0 No. of CAPAs that crossed timeline, but closed: 0 No. of overdue open CAPAs: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:28:08 great Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:28:08 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:21:25 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:02:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:55:07
REVIEW OF CHANGE CONTROLS
Total no. of change control inititated: 16 No. of change control closed: 7 No. of change control open: 9 No. of change control of previous rev. period closed in this 0 No. of change control of previous rev. period still open at 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:29:11 good Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:29:11 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:23:41 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:10:59
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:03:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:56:32
REVIEW OF ACCELERATED STABILITY MONITORING
PROGRAM
Reviewed Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
REVIEW OF LONG TERM STABILITY MONITORING
PROGRAM
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:42:14 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:42:14 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:24:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
REVIEW OF INTERMEDIATE STABILITY MONITORING
PROGRAM
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:42:14 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:24:55 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:12:42 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:26:06 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 17:30:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 13:09:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 14:35:34 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:25:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 20:06:13 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :21/10/2015 at 23:23:35 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:57:31
REVIEW OF CUSTOMER COMPLAINTS
Total no. of complains received during this review period:NIL No. of complaint investigation closed:NIL No. of investigation open:NIL No. of complaints of previous review period closed in this review period: 0 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32
REVIEW OF RETURNED GOODS
No. of returns goods notification received during this review period:NIL No. of return goods notification closed:NIL No. of return goods notification open:NIL No. of batches returned during this review period:NIL Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32
REVIEW OF RECALLS
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 21:43:15 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :05/10/2015 at 22:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:13:12 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 14:30:03 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :12/10/2015 at 18:06:16 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 16:26:32Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
REVIEW OF PROCESS VALIDATION ACTIVITIES
reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38
REVIEW OF CLEANING VALIDATION ACTIVITIES
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:43:55 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:44:13 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:26:53 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:04 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:01 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:29:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:58:38Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:45:28 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:45:28 reviewed
ANNUAL REVIEW REPORT- PRODUCT
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CTO UNIT-IV
Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
REVIEW OF REGULATORY FILING STATUS
Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:47 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:27:56 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:14:30 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:30:52 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:59:27
REVIEW OF RETAINED SAMPLES (FINISHED
PRODUCT
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:46:19 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:46:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:28:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:28:48 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:15:08 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:31:33 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:00:28
REVIEW OF LAST ARR
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:19 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:07:25 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:47:38 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:48:24 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
:06/10/2015 at 11:26:43 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:46:28 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:38
REVIEW OF STARTING MATERIALS FROM NEW
SOURCE
Reviewed Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:07:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 15:59:23 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35Total no. of vendors approved during the review period:NIL Total no. of vendor evaluation under progress during the review period:NIL Total no. of vendor rejected/blocked during the review period:NIL Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at17:32:00 ssss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:32:00 OK reviewed
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
REVIEW OF PACKAGING MATERIALS FROM NEW
SOURCE
Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 17:35:36 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:13:50 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 23:12:44 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:07:54 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at 15:59:23 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:51:35
REVIEW OF OOS RESULTS
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52
REVIEW OF OOT RESULTS
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:07 sss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:07 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:19:54 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:05 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:09 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:53:52Reprocessed batch nos. that failed meeting specification: 0 ,ADIH001371
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
REVIEW OF REPROCESS & REWORK
Reworked batch nos. that failed meeting specification: 0 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:26:58 ss Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 21:26:58 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:20:39 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:09:40 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:01:47 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at 23:54:27Total no. of batches analyzed during the review period: 80 No. ofbatches approved during the review period: 74 No. of batches rejectedduring this review period: 6 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 50.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Particle size by Laserdiffraction (Limit: NLT 90.0 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 *Tapped density (LIMIT:):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,
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CTO UNIT-IV
Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Quality Trend for Finished Material200001445_200001445_S
-08-OI-P
ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Assay by HPLC (Onanhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Melting Point( Limit:Between188.0 and 194.0 °C):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC (Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Related Substances by HPLC(Method-1) ( Limit: NMT 0.1 %):ADIH000005,ADIH000580,ADIH001358 Related Substances by HPLC(Method-1) ( Limit: NMT 0.2 %):ADHH003162,ADHH003163,ADHH003195,ADHH003196,ADHH003240,ADHH003241,ADHH003499,ADHH003500,ADHH003527,ADHH003528,ADHH003587,ADHH003612,ADHH003615,ADHH003637,ADHH003638,ADHH003668,ADHH003696,ADHH003697,ADHH003849,ADHH003855,ADHH003856,ADHH003857,ADHH003859,ADHH003860,ADHH003914,ADHH003915,ADHH003939,ADHH003940,ADHH003941,ADHH003942,ADIH000005,ADIH000006,ADIH000037,ADIH000302,ADIH000303,ADIH000339,ADIH000340,ADIH000524,ADIH000525,ADIH000526,ADIH000527,ADIH000528,ADIH000529,ADIH000579,ADIH000580,ADIH000609,ADIH000610,ADIH000663,ADIH000664,ADIH000796,ADIH000814,ADIH000815,ADIH000816,ADIH000817,ADIH000903,ADIH000904,ADIH000905,ADIH000906,ADIH000942,ADIH000982,ADIH000983,ADIH000988,ADIH000989,ADIH001101,ADIH001102,ADIH001103,ADIH001104,ADIH001105,ADIH001106,ADIH001191,ADIH001192,ADIH001194,ADIH001241,ADIH001249,ADIH001274,ADIH001275,ADIH001356,ADIH001357,ADIH001358,ADIH001405 Created By :HP -Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at21:52:02 okreviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 05/10/2015 at 21:52:02 reviewed Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:35:08
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
OkReviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214) On : 12/10/2015 at 14:43:43 ssss Modified By : HP - AdinarayanaReddy Chennepalli ( P90003214 ) On : 12/10/2015 at16:47:04 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:08:11 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:08:33 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:28:50 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:27:18 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:34:28 stested by pandu Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:16:35 SSSSSast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:05:09Total no. of batches analyzed during the review period: 30 No. ofbatches approved during the review period: 30 No. of batches rejectedduring this review period: 0 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: *Particle size byLaser diffraction (Limit: NLT 100.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 50.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,
ANNUAL REVIEW REPORT- PRODUCT
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CTO UNIT-IV
Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Quality Trend for Finished Material200001445_200001445_S
-08-OI-P
ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Particle size byLaser diffraction (Limit: NLT 90.0 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 *Tapped density (LIMIT:):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Assay byHPLC (On anhydrous basis)( Limit: Between98.0 and 102.0 %w/w):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Melting Point(Limit: Between188.0 and 194.0 °C):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC ( Limit: NMT 0.2 %):ADIH001193,ADIH001419,ADIH001474,ADIH001475,ADIH001579,ADIH001580,ADIH001581,ADIH001582,ADIH001583,ADIH001584,ADIH001640,ADIH001663,ADIH001666,ADIH001667,ADIH001724,ADIH001725,ADIH001833,ADIH001834,ADIH001835,ADIH001882,ADIH001883,ADIH001884,ADIH001910,ADIH001911,ADIH001935,ADIH001936,ADIH001987,ADIH001988,ADIH002007,ADIH002009 Related Substancesby HPLC (Method-1) ( Limit: NMT 0.1 %):ADIH001724,ADIH001911 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:55:22
ANNUAL REVIEW REPORT- PRODUCT
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CTO UNIT-IV
Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Ok reviewed ModifiedBy : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015at 21:55:22 reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 05/10/2015 at 22:37:54 Ok Reviewed Modified By : HP- Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:52:10 sss Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:10:17 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:17:47 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:33:48 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:29:49 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 23:37:32 SSS Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at14:32:18ast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:34:11Total no. of batches analyzed during the review period: 71 No. ofbatches approved during the review period: 69 No. of batches rejectedduring this review period: 2 No. of batches falling outside +3Sigma: 0 No. of batches falling outside -3 Sigma: **Particle size byLaser diffraction (Limit: NLT 100.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 50.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 **Particle size by Laser diffraction (Limit: NLT 90.0 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Assay by HPLC (On dried basis)( Limit: Between98.0 and102.0 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Quality Trend for Finished Material200001445_200001445_S
-08-OI/1
ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Loss on drying ( Limit: NMT 0.5 %w/w):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Melting point( Limit: Between188.0 and 194.0 °C):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Related Substances by HPLC : Any other Impurity ( Limit:NMT 0.1 %):
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960 Related Substances by HPLC : LIP-2 quarternary salt (Limit: NMT 0.2 %):ADHH002993,ADHH003012,ADHH003021,ADHH003060,ADHH003086,ADHH003101,ADHH003102,ADHH003108,ADHH003228,ADHH003239,ADHH003270,ADHH003305,ADHH003543,ADHH003544,ADHH003571,ADHH003586,ADHH003613,ADHH003614,ADHH003667,ADHH003688,ADHH003943,ADHH003989,ADHH004012,ADHH004013,ADHH004014,ADHH004015,ADHH004016,ADHH004041,ADHH004061,ADHH004062,ADIH000038,ADIH000039,ADIH000051,ADIH000170,ADIH000171,ADIH000172,ADIH000197,ADIH000198,ADIH000225,ADIH000226,ADIH000227,ADIH000271,ADIH000272,ADIH000285,ADIH000286,ADIH000354,ADIH000355,ADIH000375,ADIH000376,ADIH000642,ADIH000643,ADIH000818,ADIH000874,ADIH000890,ADIH000902,ADIH001270,ADIH001271,ADIH001272,ADIH001273,ADIH001333,ADIH001359,ADIH001371,ADIH001372,ADIH001404,ADIH001418,ADIH001639,ADIH001664,ADIH001958,ADIH001959,ADIH001960,ADIH001962 Created By :HP - Adinarayana ReddyChennepalli(P90003214) On :05/10/2015at21:58:43 Reviewed Modified By :HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at21:58:43 reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 05/10/2015 at 22:40:21 Ok Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at14:55:52 Ok Reviewed Modified By : HP - Adinarayana Reddy Chennepalli( P90003214 ) On : 12/10/2015 at 14:56:10 ss Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 12/10/2015 at23:24:07 ss
ANNUAL REVIEW REPORT- PRODUCT
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Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
22.0 SUMMARY REPORT:
Name of the Section Final Summary
Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 12/10/2015 at 23:25:12 Reviewed Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 16/10/2015 at15:20:16 Reviewed Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 16/10/2015 at 15:39:17 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at20:33:24 ok Modified By : HP - Adinarayana Reddy Chennepalli (P90003214 ) On : 21/10/2015 at 20:34:26 ok Modified By : HP -Adinarayana Reddy Chennepalli ( P90003214 ) On : 21/10/2015 at23:41:01SSSS PANDUast Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 28/10/2015 at 22:45:59
Yield Trend for Finished Material200001445_200001445__
1004_2014
Total no. of batches manufactured during the review period:002 No. of batches failed to meet the Yield limits:002 No. of batches falling outside +3 Sigma:002 No. of batches falling outside -3 Sigma:000 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :05/10/2015at22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:24 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:04:41 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:16 reviewed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 05/10/2015 at 22:46:31 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:25:58 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:42:41
ANNUAL REVIEW REPORT- PRODUCT
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Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
Name of the Section Final Summary
Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:12:01
Yield Trend for Finished Material200001445_200001445_N
OTAPPLICABSummary of CAPAs:
CAPAs raised during this review period i. Total no. of CAPAs raised: ii. No. of CAPAs closed: iii. No. of CAPAs open: iv. No. of closed CAPAs that crossed timeline: v. No. of overdue open CAPAs: CAPAs raised till date 0 ii. No. of CAPAs generated outside the current review period, but closed during iii. No. of CAPAs generated outside the current review period, but closed during the current rev. period that crossed timelines: Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :06/10/2015 at 11:27:30 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On :16/10/2015 at 16:47:32 Last Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:13:35
ANNUAL REVIEW REPORT- PRODUCT
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172Page 172of
Name of Product: LIP-3 (OLANZAPINE CANADIAN MKT)
ARR No.:PARR - 04 - 2014 - LIP-3 (OLANZAPINE CANADIAN MKT) - 200144229
Reviewed Period: October-2014 to October-2015
23.1 Open Items:
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:10 Nill Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21
23.2 Comments:
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21
23.3 CONCLUSION AND RECOMMENDATIONS:
Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Created By :HP - Adinarayana Reddy Chennepalli(P90003214) On :06/10/2015at11:28:34 Reviwed Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 06/10/2015 at 11:28:34 Modified By : HP - Adinarayana Reddy Chennepalli ( P90003214 ) On : 22/10/2015 at 00:14:21