issuing, handling, revision of batch file and final release of finished products for sale and...

7/30/2019 Issuing, Handling, Revision of Batch File and Final Release of Finished Products for Sale and Distribution 07

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T3A INDUSTRIAL

Doc # AP-12-1035 Issue # 07 Page 1 of 18

STANDARD OPERATING PROCEDURE

Title: ISSUING, HANDLING, REVIEW OF BATCH FILE

BEFORE FINAL RELEASE OF FINISHED PRODUCTS

ASSIGNEE NAME TITLE SIGN./DATE

PREPARED BY MOHAMED GHAZALY S.QA OFFICER

REVIEWED BY MOHAMED EL-SAADY QA Supervisor

APPROVED BY AHMED SALAH QA MANAGER

HISTORY OF CHANGE

ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE

Issue 001to

Issue 002

31/01/2000 8 & 91. Change in items of release procedures.

2. Adding four attachments of checklists to be

used in the batch evaluation for release

Issue 002 toIssue 003

06/01/02All pages

1. Change the document title.

2. Change the scope3. Change the responsibility

4. Change the procedures.

5. Change the attachments

Issue 003 toIssue 004

11/05/03

2

3

67

8-34

1. Addition the point 3.1.2.1

2. Changing the point 3.4.2

3. Addition the point 4.9.2.1.204. Addition the point 4.10.2

5. Change the attachmentsIssue 004 to

Issue 00531/08/2004

1,

7

1. Change the assignee persons.

2. Change the attachment 5.1

Issue 005 to

Issue 0618/07/2005 All pages

1. Change in document format.

2. Change in assignee persons.

Issue 06 to

Issue 07

15/10/2006 All pages 1. Rewording for the all SOP.

2. Modifying in items 4.3& 4.5.3. Canceling for item 4.9, 4.9.2.1, 4.9.2.1.12 ,

4.9.2.1.20 and Attachments No. 5.2& 5.3

ISSUE DATE: //. EFFECTIVE DATE: //. REVISION DATE: //.


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ISSUE # ISSUE DATE PAGE # SUMMARY OF CHANGE

from the old issue.

4. Division for Item 3.3 to 3.3 and 3.4.5. Addition for item 4.10.

6. Change in attachments 5.1, 5.2, 5.3& 5.4.7. Change in page numbers.

8. Change in the format unique numbers.

9. Change in Assignee persons.

1. OBJECTIVE:

1.1. To establish the issuing, handling and reviewing of batch file before final release of

finished products.

2. SCOPE:2.1. Applies to all product batches, which processed or packaged in T3A facilities.

3. RESPONSIBILITY:

3.1. Production documentation officer or designee: Issuing and delivering of

manufacturing orders to QA Department, receiving the batch record from QA

department and delivering the issued and stamped batch record to the productionsupervisor.

3.2. Production manager or designee: review, approves the manufacturing order andreviewing the batch file.

3.3. Manufacturing operators each on his line: recording, and attaching the required data.3.4. Manufacturing section head/supervisor or designee: checking the processing

procedure and recorded parameters.

3.5. Warehouse weighing responsible person or designee: recording, Labeling anddelivering the batch file with the materials to production section.

3.6. IPC Person or designee: checking, sampling, testing and recording during the

different stages of manufacturing.3.7. QC analyst or designee: performing all required analysis for the product and issuing

the analysis report.

3.8. QC supervisor or designee: reviewing the analysis results and issuing the certificateof analysis.

3.9. QC manger or designee: reviewing and approval the analysis package and certificate.

3.10. QA documentation officer or designee: Issuing the needed batch record.

3.11. QA batch reviewing officer or designee: Receiving the issued manufacturing order,delivering, collecting, reviewing and archiving the batch Manufacturing records.

3.12. QA Supervisor or designee: reviewing the batch file.

3.13. QA Manager or designee: finally reviewing for approval the batch file.______________________________________________________________________________________________

PREPARED BY: REVIEWED BY: ... APPROVED BY: ..


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4. PROCEDURE:4.1.Issue the processing/packaging order and deliver it to QA Batch reviewing officer.

4.2.Issuing of batch records shall be done as follows:

4.2.1.Make a complete; legible & clear photocopy of the last original approved master batchprocessing & packaging records of the requested product.

4.2.2. Stamp the batch number (from manufacturing order) on each batch page of the

stamped copy (valid copy) of batch processing/packaging record.

4.2.3.Record the product name & its batch number in the batch record logbook (seeattachment 5.1.) and obtain production responsible officer signature.

4.3.Deliver the batch processing/packaging record to the specified production section.

4.4. Record all required data for processing/packaging components in the first page ofbatch processing/packaging record and record any deviations if found, then deliver it to

processing/packaging responsible person

4.5. Record all the required data in time and attach the used formats, printout and labels to

the batch record; then deliver it after finishing the operation to the section supervisor.4.6. Collect all documents relevant to the batch record, and deliver it to processing/

packaging section head.

4.7. Check that all documents of the batch record are clear, complete, legible & arranged ina logical manner.

4.8. Review the batch file (processing/ packaging records) including the QC-IPC

documents; then deliver it to QA department.4.9. Review the whole enclosed documents as follows:

4.9.1. Ensure that the used documents are the latest approved ones.

4.9.2. Check the presence of all required cleaning labels in processing and packaging records.4.9.3. Ensure the presence of all required signatures in the specified spaces (double

signatures as required).4.9.4. Assure that all parameters of processes are fulfilled and within their specified limits.4.9.5. Compare the yield from each step against the standard yield which expected from each

step and investigate the reason of low/ high yield.

4.9.6. Review any calculation used during the different production processes, review the

correction of all documents related to such calculations.4.9.7. Review all overprinting approval of printed data for packaging material.

4.9.8. Compare the final yield from packaging with final yield from process, correlation shall

be logic.4.9.9. Compare the dates in processing & packaging, they shall be logically sequenced.

4.9.10. Compare the data in the destruction sheet of packaging materials during reviewing of

the reconciliation sheet.4.9.11. Review all prints-out of the processing machine and compare them to the recorded data

in batch manufacturing records for the accuracy of recording (assure the presence of

signatures and dates on each print-out).

4.9.12. In case of reprocessing, the approval (and any investigation documents) shall bereviewed.

______________________________________________________________________________________________



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4.9.13.In case of adding recovered materials to the batch under processing, the batch numberof these materials shall be recorded.

4.9.14.Review the environmental data printouts, for conformance to the specific

environmental conditions required for each process for a particular product.4.9.15.Check catalogue (or samples) of printed packaging materials to ensure that: All pre-printed data are clear and correctly positioned. All printed data (e.g. Mfg. & Exp.

dates etc...) are correct, stable, clearly visible and in the correct place.

4.9.16.Ensure that the processing & packaging in-process controls are done as specified indue time and covering all processing times (all shifts).

4.9.17.Reviewing quality control testing records ( Physical, chemical and microbiology)

4.9.17.1.Check the QC release for intermediate, semi-finished and finished products (asindicated in the analysis request) prior to proceeding for further revisions.

4.9.18.QC department responsible for archiving the following documents: Analysis package

and prints out (Chromatograms, Spectrumetc) and environmental monitoringreports.

4.9.19.The batch records shall be retained for one year after the expiry date of the batch and

at least 5 years after the certification.

5. ATTACHMENT:

5.1. Batch record follow uplogbook

5.2. Batch file final reviewing checklist for sterile products

5.3. Batch file final reviewing checklist for solids5.4. Batch file final reviewing checklist for semi-solids and liquids

______________________________________________________________________________________________



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5.1 Batch Record follow up logbook: (Format Unique # 0046)

Product name

Batch Number

Batchrecords-befo

re

processing

ProductionSign/ Date

BPR

BPKR

QA

Sign/ Date

BPR

BPKR

Batchreco

rds-after

processing

Production

Sign/ Date

BPR

BPKR

QA

Sign/ Date

BPR

BPKR

QC

C.O.A

QC Sign/ Date

Decision


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QA

BPR Reviewed by

BPKR Reviewed by

Final Decision

Location

_______________________________________________________________________________________

ARED BY: REVIEWED BY: ... APPROVED BY: ..

_________________________________________________________________________________________________________

ARED BY: REVIEWED BY: ... APPROVED BY: ..

Page ( ) of ( )


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5.2. Batch file final reviewing checklist for Sterile products: (Format Unique # 0047)

Product Name: Batch #:

Document name Availability Remarks

(General common documents for processing)

Processing order (or a copy)

All pages of BPR are completedand stamped

Cleaning labels

Processing labels

Dispensing labels

A copy of rejection form ( if any)

A copy of Return order ( if any)

Material request

Print out of tunnel

Deviation report (if any)

Print out of autoclave

Load description of autoclave

Page 1 of 4

______________________________________________________________________________________________



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Product Name: Batch # :

(Packaging documents for Vials) (LMMOHExportExport FMS FMS Other ..)(packaging documents for vials) Availability Remarks

A copy of packaging order.

All pages of BPkR are completed and stamped.

Cleaning labels

Processing labels

Weighing center labels.

A copy of rejection order (if any).

A copy of return order) if any).

A copy of material request (if any).

Deviation report (If any)

A copy of finished product delivery order.

Attached signed overprinted boxes.

Attached signed folded pamphlets.

Attached signed specimen of overprinted labels.

Page 2 of 4

Reconciliation for Vials______________________________________________________________________________________________



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Comments: ........................................................................................................................................................................................................................................................................................................................................................

Page 3 of 4

Remarks for processing section:.

.

______________________________________________________________________________________________


Product Name: Batch Number:

Theoretical batch size : Actual batch size:

Manufacturing date: Expiry date:

Manufacturing started on: Manufacturing ended on :Packaging Started on : Packaging ended on :

Using the last update approved document : Logical sequence of processing/packaging dates :

Presence of QC certificate of analysis :

Material received produced Loss %

Vials

Rubbers

powder

Filled Vials

Caps

Pamphlets

Labels

Boxes


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Reply of the department:

.

.Reviewed by: Sign/ date

Remarks for packaging section:

..

.


..

.

Reviewed by: Sign/ date

Remarks for Quality Control:

.

..


.


QA Comment:

......

...

Conclusion:

the Batch Manufacturing Records are (not) complying with GMP regulations.

The batch is (not) released for sale.

The batch records are reviewed by QA supervisor Quality Assurance manager

. ........Page 4 of 4

5.3. Batch file final reviewing checklist for Solids: (Format Unique # 0048)



(General common documents)______________________________________________________________________________________________



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All pages of BPR are completed and stamped


Cleaning labels

Processing labels

Dispensing labels

Analysis requests

A copy of rejection form (if any)

A copy of Return order (if any)

A copy of Material request ( if any)

Deviation report ( if any)

IPC report

Recovery Approval ( if any)

Page 1 of 4

______________________________________________________________________________________________



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Product Name: Batch # :

(Packaging documents for solids) (LMMOHExport Export FMS FMS Other )

(packaging documents for solids) Availability

Remarks


All pages of BPkR are complete and stamped.

Cleaning labels

Processing labels

Weighing centre labels.



Deviation report (if any).


A copy of finished product delivery order.

Attached specimen of Alu. Foil from each reelused in the blistering.

Attached signed overprinted boxes.

Attached signed folded pamphlets.

Attached signed specimen of overprinted labels.

Page 2 of 4

Reconciliation for Solids

______________________________________________________________________________________________



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Starting material

Capsules

Bulk product

Bottles

Cap

Pamphlets

PVC / PVDCLabels

Boxes

AL foil

Dossier

Comments: ........................................................................................................................................................................................................................................................................................................................................................

Page 3 of 4

Remarks for processing section:

.

______________________________________________________________________________________________


Product Name : Batch Number :

Theoretical batch size : Actual batch size :

Manufacturing date : Expiry date :

Manufacturing started on : Manufacturing ended on :

Packaging Started on : Packaging ended on :




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.Reply of the department:

..


Remarks for packaging section:

.

.


.

..


Remarks for Quality Control:.

.



QA Comment:

......

...

..

Conclusion:

the Batch Manufacturing Records are (not) complying with GMP regulations.



. ........

Page 4 of 4

5.4. Batch file final reviewing checklist for Semi-Solids and Liquids: (Format Unique # 0049)

______________________________________________________________________________________________



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(General common documents)

All pages of BPR is completed and stamped


Cleaning labels

Processing labels

Dispensing labels

Analysis requests

A copy of rejection form ( if any)

A copy of return order ( if any)

A copy of material request ( if any)

Deviation report ( if any)

Sample tube

Recovery Approval ( if any)

Page 1 of 4

______________________________________________________________________________________________



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Page 2 of 4

Reconciliation for Semi-Solids______________________________________________________________________________________________


Product Name : Batch # :

(Packaging documents for semi-solids and Liquids) (LMMOHExportExport FMS FMSOth

.)

(packaging documents for semi-solids) Availability Remarks

All pages of BPkR are completed and stamped.


Cleaning labels

Processing labels

Weighing centre labels.



Deviation report (if any).


A copy of finished product delivery order

Attached signed overprinted boxes

Attached signed folded pamphlets

Attached signed specimen of overprinted labels


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Starting material

Bulk product

Filled [Bottle/tube]

Tubes

Bottles

Dossier

Cap

Pamphlets

Labels

Boxes

Comments:..........................................................................................................................................................................................................................................................................................................................................................................

Page 3 of 4

Remarks for processing section:

.

______________________________________________________________________________________________


Product Name : Batch Number :

Theoretical batch size : Actual batch size :Manufacturing date : Expiry date :

Manufacturing started on : Manufacturing ended on :

Packaging Started on : Packaging ended on :




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.

Reply of the department:.


Remarks for packaging section:.

.

.

Reply of the department:.

.


Remarks for Quality Control:

..

.


.


QA Comment:

...................................

...

..

Conclusion:

The Batch Manufacturing Records are (not) complying with GMP regulations.



. ........

Page 4 of 4

______________________________________________________________________________________________


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