sop of production department

SARTHAK BIOTECH PVT

SARTHAK BIOTECH Pvt. Ltd.

198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.)

STANDARD OPERATING PROCEDURE

INDEX OF PRODUCTION SOPS

Sr. NoName of the SOPCategory/SOP No.Rmk

1.SOP FOR Preparation of Sanitizing SolutionSPD/01

2.SOP FOR Rodents, Insects & Birds Control in ProductionSPD/02

3.SOP FOR Cleaning and Operation of Air Handling Unit Pre FiltersSPD/03

4.SOP FOR Disposal of Expired Finished GoodsSPD/04

5.SOP FOR Building MaintenanceSPD/05

6.SOP FOR Disposal of ExceSs/ Rejected Packing MaterialSPD/06

7.SOP for Entry/ Exit of Visitors in Manufacturing AreaSPD/07

8.SOP for Entry into Production AreaSPD/08

9.SOP for Safety PracticesSPD/09

10.SOP for Log Book SystemSPD/10

11.SOP for Environment MonitoringSPD/11

12.SOP FOR Removal of Scrap from Production AreaSPD/12

13.SOP FOR Disposal of Empty ContainersSPD/13

14.SOP FOR Cleaning of General DressesSPD/14

15.SOP for Cleaning and Sanitation of General area production blockSPD/15

16.SOP FOR Calibration and Operation of Weighing BalanceSPD/16

17.SOP FOR Cleaning and Operation of Manual Capsule Filling MachineSPD/17

18.SOP FOR Cleaning and Operation of Blister Packing MachineSPD/18

19.SOP FOR Cleaning and Operation of Double Cone BlenderSPD/19

20.SOP FOR Cleaning and Operation of Dry Filling MachineSPD/20

21.SOP FOR Cleaning and Operation of ROPP Cap Bottle Sealing MachineSPD/21

22.SOP FOR Decartoning of Containers and ClosuresSPD/22

23.SOP FOR Controlling Microbial Contamination (Ointment Section)SPD/23

24.SOP FOR Procedure for Line Clearance ( Packing)SPD/24

25.SOP FOR Visual InspectionSPD/25

26.SOP FOR Batch CodingSPD/26

27.SOP FOR Reprocessing of RecoverySPD/27

28.SOP FOR Leak Test for Capsules/ Tablets (Strip and Blister Packing)SPD/28

29.SOP FOR Cleaning & Operation of Capsule LoaderSPD/29

30.SOP FOR Cleaning & Operation of DehumidifierSPD/30

31.SOP FOR Cleaning & Operation of Strip Packing MachineSPD/31

32.SOP FOR Cleaning & Operation of SifterSPD/32

33.SOP FOR Handling of Finished Products in StoreSPD/33

34.SOP FOR Packing OperationSPD/34

35.SOP for Cleaning of Paste KettleSPD/35

36.SOP for General Cleaning of Equipment in Manufacturing AreaSPD/36

37.SOP for Adverse Health Condition of person in Manufacturing AreaSPD/37

38SOP for Internal Labeling during Quarantine, Storage and Processing SPD/38

39.SOP for receipt of Packing Material in ProductionSPD/39

40.SOP for Disposal & Salvage of Rejected / Expired / Unusable MaterialSSPD/40

41.SOP for the Waste Collection from Production AREASPD/41

42.SOP FOR Cleaning of Conventional Coating PanSPD/42

43.SOP FOR Cleaning of Fluidized Bed DryerSPD/43

44.SOP FOR Cleaning AND OPERATION of MultimillSPD/44

45.SOP FOR Cleaning of Polishing PanSPD/45

46.SOP FOR Cleaning and Operation of Capsule Filling Machine (SEMI AUTO MATIC)SPD/46

47.SOP FOR Cleaning of Spray GunSPD/47

48.SOP FOR Cleaning of TableT DepartmentSPD/48

49.SOP FOR Paste Preparation VesselSPD/49

50.SOP FOR Disposal Operation in Tablet DepartmentSPD/50

51.SOP FOR Cleaning & Assembling of Compression Machine SPD/51

52.SOP FOR Tablet Compression ToolingSPD/52

53.SOP FOR Storage of In-process Tablets & GranulesSPD/53

54.SOP FOR Operation of Fluidized Bed DryerSPD/54

55.SOP FOR Cleaning AND OPERATION of Mass MixerSPD/55

56.SOP FOR Tablets InspectionSPD/56

57.SOP FOR House Keeping in Tablet Compression SECTIONSPD/57

58.SOP FOR House Keeping in Tablet Packing AreaSPD/58

59.SOP FOR Cleaning of Manufacturing Vessel (Topical Section)SPD/59

60.SOP FOR Cleaning of Bulk Tank (Topical Section)SPD/60

61.SOP FOR Cleaning and Assembling of Tube Filling Machine (Topical Section)SPD/61

62.SOP FOR Polishing of CapsulesSPD/62

63.SOP FOR Cleaning of S.S. Wax Melting Vessel (Topical Section)SPD/63

64.SOP FOR Polishing of Punches and DiesSPD/64

65.SOP FOR Cleaning of Utensils, Scrapper,SPOONS & Scoops (Topical Section)SPD/65

66.SOP FOR Removal of Bulk from Tube Filling Machine (Topical Section)SPD/66

67.SOP FOR In-Process Control IN Manufacturing (Topical Section)SPD/67

68.SOP FOR House Keeping IN Topical SectionSPD/68

69.SOP FOR Installation of New Punch SetSPD/69

70.SOP FOR In-Process Packing ( Topical Section)SPD/70

71.SOP FOR Line Clearance (Topical Section)SPD/71

72.SOP FOR Cleaning of S.S. Water Vessel (Topical Section)SPD/72

73.SOP FOR In-Process Fill Weight DeterminationSPD/73

74.SOP FOR LABELLING & PACKING OF ORAL LIQUIDSPD/74

75.SOP FOR CLEANING OF GENERAL UTENSILS, SS CONTAINERSSPD/75

76.SOP FOR CLEANING OF MANUFACTUIRNG AREA (TABLET, CAPSULE & LIQUID ORALS)SPD/76

77.SOP FOR CLEANING OF S.S. CONTAINERS, PRESSURE VESSELS, S.S. TANKS & STIRRERSPD/77

78.SOP FOR CLEANING OF CONVEYOR BELTSPD/78

79.SOP FOR OPERATION & CLEANING OF BOTTLE FILLING MACHINESPD/79

80.SOP FOR OPERATION & CLEANING OF BOTTLE WASHING MACHINE SPD/80

81.SOP FOR OPERATION & CLEANING OF COLLOIDAL MILLSPD/81

82.SOP FOR OPERATION & CLEANING OF HIGH SPEED STIRRERSPD/82

83.SOP FOR OPERATION & CLEANING OF FILTER PRESSSPD/83

84.SOP FOR OPERATION & CLEANING OF PP CAP SEALING MACHINESPD/84

85.SOP FOR VISUAL INSPECTION OF LIQUID ORALSSPD/85

86.SOP FOR CLEANING OF S.S. TANKS & STIRRER (LIQUID SECTION)SPD/86

87.SOP FOR MIXING, GRANULATION & PUNCHINGSPD/87

88.SOP FOR STRIP VISUAL INSPECTIONSPD/88

89.SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE (ROTARY MACHINE)SPD/89

90.SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION MACHINE (MULTI PUNCHING MACHINE)SPD/90

91.SOP FOR OPERATION OF TUBE FILLING , SEALING ,CLEANING, CRIMPING & BATCH CODING MACHINE (TOPICAL SECTION)spd/91

92.SOP FOR INSPECTION, CLEANING & PACKING OF TUBESSPD/92

93.SOP FOR BATCH DESTRUCTIONSPD/93

94.SOP FOR CLEANING & OPERATION OF PLANETARY MIXERSPD/94

95.SOP FOR CLEANING, OPERATION & MAINTENANCE OF COLLOIDAL MILL.SPD/95

96.SOP FOR WASHING & CLEANING OF EQUIPMENTS (EXTERNAL PREPARATION SECTION)SPD/96

97.SOP FOR BATCH PREPARATION OF EXTERNAL PREPARATIONSPD/97

98.SOP FOR WASHING, CLEANING & STORAGE OF EQUIPMENT, VESSELS, & STIRRER MACHINE PARTS FOR OINTMENT & CREAM.SPD/98

99.SOP FOR COATING PANSPD/99

100.SOP FOR TRANSFER OF FINISHED GOODS TO FINISHED GOODS STORESPD/100

101.SOP FOR OPERATION AND CLEANING OF TRAY DRIERSPD/101

102.SOP FOR OPERATION AND CLEANING OF ALU-ALU PACK MACHINESPD/102

103.SOP FOR OPERATING OF AIR COMPRESSORSPD/103

104.SOP FOR OVER PRINTING ON STRIPSSPD/104

105.SOP FOR LEAKAGE CHECKS IN FILLED BOTTLESPD/105

106.SOP FOR OVER PRINTING ON BOXES AND LABELSSPD/106

TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTIONPage : 01-02 Deptt.: PRODUCTION

SOP NO. : SPD/01Effective Date: 15-07-2007Revision No.:Review Date: 14-07-2009

Prepared by:Asstt. Production ChemistChecked By:Production ManagerApproved By

Q.A. ManagerDirector

Sign.Sign..Sign....Sign...

1) PURPOSE:To lay down a Procedure for Preparation of Sanitizing Solution.2) RESPONSIBILITY:Q/C Manager.

3) ACCOUNTABILITY:Production Manager/Q.A. Manager

4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:

5.1 Preparation of Sanitizing Solution5.1.170% Isopropyl Alcohol in D. M. water.Take 700ml IPA in a measuring cylinder. Add sufficient quantity of D.M.water to make 1.0-Liter solution.

5.1.22% Savlon solution in D.M water.Take 20ml Savlon Solution in a measuring cylinder and make 1.0 liter using DM water.5.1.3 2% Dettol solution in D M waterTake 20ml Dettol Solution in a measuring cylinder and make 1.0 liter using DM water.5.1.45% Phenol solution in DM water.

Heat the bottle containing Phenol in a water bath till it melts.Take 50ml liquified Phenol in a measuring cylinder and make volume up to 1.0 liters by using DM water.

TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTIONPage : 02-02

Deptt.: PRODUCTION

SOP NO. : SPD/01Effective Date: 15-07-2007Revision No.:Review Date: 14-07-2009

Prepared by:

Asstt. Production ChemistChecked By:

Production ManagerApproved By



5.1.54% v/v Hydrogen Peroxide solution in Distilled waterTake 40 ml Hydrogen Peroxide in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters.

5.1.6 2% v/v Benzalkonium Chloride solution in Distilled waterTake 20ml Benzalkonium Chloride in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters.

5.1.7 2% v/v Glyceraldehyde solution in Distilled water

Take 20ml Glyceraldehyde in a measuring cylinder and add distilled water to make volume 1.0 liters.Note: All these preparations are prepared in third air lock.

5.2 Precaution: Wear Gloves, Mask & Goggles before preparing sanitizing solution.TITLE: SOP FOR RODENTS, INSECTS & BIRDS CONTROL IN PRODUCTIONPage : 01-01

Deptt.: PRODUCTION

SOP NO.: SPD/02Effective Date: 15-07-2007Revision No.:Review Date: 14-07-2009

Prepared by:




Sign.Sign..Sign.......Sign...

1) PURPOSE: To lay down procedure of control of rodents, insects and birds to be carried out by the approved contractor.

2) RESPONSIBILITY: Q.A. Manager

3) ACCOUNTABILITY: Production Manager/ Q A Manager.

4) SCOPE: The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.

5) PROCEDURE:

5.1 The approved contractor is deputing for control of birds, redents and insects by applying the chemical. Birds repellents, nets sieves repellents i.e. UV repellent (blue light), flycatcher, door nets are fixe on all entries. For insect control, company has placed at all the entry-exit place, double door, one with wire mesh, other with wooden & glass doors, with the facility of door closer.

5.2 Entries doors are installe with are Curtains to avoid entry of insects.5.3 The contractor come twice every month or whenever called to review the situation.

TITLE: SOP FOR CLEANING & OPERATION OF AIR HANDLING UNIT PRE FILTERSPage : 01-01

Deptt.: PRODUCTION


Prepared by:




Sign...Sign..Sign....Sign...

1 PURPOSE:To lay down a Procedure for Cleaning and Operation of Air Handling Unit Pre-Filters.

2 RESPONSIBILITY:Q/C Manager.

3 ACCOUNTABILITY:Production Manager/Q.A. Manager

4 SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5 PROCEDURE:

5.1 Cleaning of pre-filter 20 micron average 7-15 days i.e. .weakly off day.

5.2 Cleaning of pre-filter cabinet is carried out side of the production area.

1) CLEANING:6.1 Before cleaning of the AHU pre-filter, switch OFF the mains.

6.2 Loosen the filter cabinet bolts.

6.3 Remove the filter cabinet set aside.

6.4 Close the AHU filter cabinet with poly bag till the filter is ready to be fixed.

6.5 Clear the filter by compressed air at least for five times with airflow in reverse of the operational flow direction, out side the production area.

6.6 Wash the pre-filters using mild soap solution and then with running tap water.

6.7 Pass the compressed air through the other side of the filter and then dry the filter.

6.8 Remove the poly bag from dust.

6.9 Clean the filter cabinet with dry clothes.

6.10 Fix the pre-filter and tight cabinet bolts.

6.11 Record the cleaning operation of pre-filters in prescribed format.TITLE: SOP FOR DISPOSAL OF EXPIRED FINISHED GOODSPage : 01-01

Deptt.: PRODUCTION


Prepared by:




Sign..Sign....Sign....Sign...

6) PURPOSE:To lay down a Procedure for Disposal of Expired Finished Goods.

7) RESPONSIBILITY:Q/C Manager.



5.1 All the finished goods are carried to the disposal area in the final packed form. Take out the inner carton from the shipper & finally take out the Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment from the inner cartons.

5.2 In case of Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment, submerge them in water to dissolve & after dissolution, dump the slurry or solution into a ditch. In case of Oral Liquid, break the seal of bottles, take out the liquid or solution into a bucket & put it into the ditch. Glass containers & seals are kept separately for sale as a waste. Shippers & inner cartons are burnt separately during packing material disposal.

5.3 The label of the labeled bottle is removed before disposal.

1) PRECAUTIONS :

6.1 Expired finished materials are not used for medicinal purpose.

6.2 Cartons or shipper or poly bags in which the finished materials were kept are separated before disposal of finished goods and disposed off separately.

6.3 Disposal done under supervision of Q.A. Head.

6.4 Poisonous or obnoxious materials are treated to neutralization before dumping.

6.5 After disposal of the material, the same is recorded.

TITLE: SOP FOR BUILDING MAINTENANCEPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Building Maintenance.




5.1 The factory maintenance is an important part of maintaining facilities to work smoothly and hygienically and periodically maintained by repairing, painting, washing, moping etc.

5.2 MAINTENANCE REQUIRED :

The following categories of the maintenance are generally required in a Pharmaceutical formulation plant.

5.2.1 Civil Maintenance

5.2.2 Electrical Maintenance

5.2.3 Utilities Maintenance

The above categories are further classified as under to decentralize the work according to need.

5.2.1 CIVIL MAINTENANCE:This includes the following parts of maintenance in a building.

5.2.1.1 Repairs of walls and floors with plastering work.

5.2.1.2 Parts on walls and other places where ever required.

5.2.1.3 Aluminum or glass work required for doors and windows.

5.2.1.4 External roads linked with the Production premises.

5.2.1.5 Insects/ Rodents protective mesh where ever provided.

TITLE: SOP FOR BUILDING MAINTENANCEPage : 02-02

Deptt.: PRODUCTION


Prepared by:





5.2.2. ELECTRICAL MAINTENANCE:5.2.2.1 Exhaust fans, Fans, Air Conditioners.

5.2.2.2 Tube lights, Insect repeller, Air curtain.

5.2.2.3 General wiring of Production premises and electrical points.

5.2.2.4 Electrical water purification system where ever applicable.

5.2.2.5 Major electrical panels.

5.2.3 UTILITIES MAINTENANCE:5.2.3.1 Cleaning and maintenance of water distribution system.

5.2.3.2 Maintenance of drainage system, sinks, taps, pipes.

5.2.3.3 Maintenance of air cooling system.

5.2.3.4 Maintenance of effluent treatment plant.

5.2.3.5 Generator system and transformer.

5.2.3.6 Lawns and plantation maintenance.

1) FREQUENCY6.1 All major repairs of production premises: Once in 6 months.

6.2 Paints: Once in 6 months in those areas where repair has been done.

Once in a year for the complete plant & factory.

6.3 For Doors and glass work: Once in 2 months.

6.4 For wire mesh: Once in 6 months.

6.5 For external roads: Once in a year.

2) MAINTENANCE PROCEDURE:7.1 The maintenance carried out when the production is not going on.

7.2 All electrical maintenance work to be done by an expert under the supervision of Companys Electrical Engineer.

7.3 All repairs are carried out on request of the concerned Department Head in writing and approval by the above referred authorized persons.

7.4 Records and log for all such repairs are maintained.TITLE: SOP FOR DISPOSAL OF EXCESS / REJECTED PACKING MATERIALPage : 01-01

Deptt.: PRODUCTION


Prepared by:




Sign...Sign...Sign....Sign...

1) PURPOSE:To lay down a Procedure for Disposal of Excess / Rejected Packing Material.




5.1 After completion of packing operation of one batch product, the packing line is checked for excess packing materials.

5.2 Excess P.M. sorted out and good / without printed packing materials is counted and tied.

5.3 All good material are returned to packing material store through material return note.

5.4 All coded unit cartons/labels are transferred to scrap yard and shredded into pieces before disposing off.

5.5 Details of all returned materials and rejected materials are recorded in packing material reconciliation sheet included in Batch Production Record.

TITLE: SOP FOR ENTRY/EXIT OF VISITORS IN MANUFACTURING AREAPage : 01-01

Deptt.: PRODUCTION


Prepared by:




Sign..Sign..Sign....Sign...

1) PURPOSE:To lay down a Procedure for Entry / Exit of Visitors in Manufacturing Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:Entry of Visitors: -

5.1 Entry of visitor to these Areas is restricted as much as possible.

5.2 Entry of visitors is given a clean lab coat, cap & mask.

5.3 Then visitors & accompanying authorized person put shoe cover on his street shoes or wear clean laboratory sleepers. They cross the barrier before entering manufacturing area. After which they are dip the footwears in to the disinfecting solution soaked mat and then into the main working area.

5.4 Before leaving the manufacturing area visitor remove the shoe cover, lab coat, cap & mask and the concerned officer send them for washing.

TITLE: SOP FOR ENTRY INTO PRODUCTION AREAPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Entry into Production Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:Before entering into any area the following norms are followed: -5.1 Wash and dry their hands.

5.2 Wear clean factory uniform, head covers, gloves, masks and foot-covers where necessary.

5.3 Workman wears head cover, facemask in such a way that the whole head, hair, moustaches and beards are covered so that particles on the hair do not contaminate the working areas.

5.4 Outside visitors when taken for a round in the operational areas should wear aprons, head-covers and foot-covers as per the requirement.

5.5 Before changing into factory uniforms, items of jewellary is removed and kept in the lockers provided.

5.6 No food or drink is carried in the production areas.

5.7 Do not eat; chew tobacco, pan or betel nuts while working.

5.8 Smoking is strictly prohibited in the production areas/ office premises.

5.9 Nails are trimmed frequently.

5.10 Use of cosmetics and perfumes are avoided as far as possible.TITLE: SOP FOR SAFETY PRACTICESPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Safety Practices.




5.1 Hand gloves and safety shoes are used in the manufacturing area. Enough, gloves, etc. are available and used when required.

5.2 Lighting and electrical fittings are flame proof. In case of hot work, there is a system to issue welding and fire permit (spark generating maintenance activity).

5.3 All safety precautions are adopted according to the needs.

TITLE: SOP FOR LOG BOOK SYSTEMPage : 01-02Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Log Book System.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:FORMAT: Log-book is maintained depending upon the user department, the log book should contain the following details:5.1 Equipment:a) Name of Equipment.

b) Code No.

c) Product & its batch number.

d) Remarks, if any

e) Signature of chemist and Signature of the person checking.

5.2Lab Instrument:a) Instrument Name

b) Sr. No.

c) Date of Analysis

d) Analysis time

e) Product analyzed & its batch number

f) A.R. No.

g) Remarks of Analysis if any

h) Signature of analyst and Signature of the person checking the analysis report.TITLE: SOP FOR LOG BOOK SYSTEMPage : 02-02

Deptt.: PRODUCTION


Prepared by:





5.3Chemist / Analysts Log Book:a)Date of analysis

b)Name of the test, analysis data and calculation details.

c)Product analyzed & its batch number

d)Signature of analyst and Signature of the person checking the analysis.

5.4Calibration Log Books:

a)Instrument Name

b)Range

c)Accuracy

d)The standard used

e)Calibration Frequency

f)Model No.

g)Signature of person calibrating the equipment / instrument and Signature of the person reviewing the calibration report.Note: If any instrument is malfunctioning or requires non-routine maintenance, work order should be generated by the Analyst / Chemist responsible for calibration of that instrument and maintenance details to be entered in instrument log book / chemist log book.

Equipment / Instrument Name

Service required data

Data repaired

Nature of repair work carried out in detail

Re-calibration data

Signature of chemist and dateTITLE: SOP FOR ENVIRONMENT MONITORINGPage : 01-03

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Environment Monitoring.




5.1 Record the temperature & humidity in the environment monitoring chart.

5.2 Regulate the A/C of Dehumidifier if the temperature of a particular area is the out of the prescribed limit.

5.3 The limit is specified below:

AreaTemperatureHumidity

Mixing Granulation & Drying28-29O C70% Max.

Blending, Compression25-27O C40-45%

Capsulation, Powder, Dry Syrup23-25O C40-45%

Beta-Lactum Capsules, Tablets23-27O C40-45%

Film Coating25-27O C50-55%Corridors25-27O C70% MaxTITLE: SOP FOR ENVIRONMENT MONITORINGPage : 02-03

Deptt.: PRODUCTION


Prepared by:





(a)Store area for

Beta Lactum

25-27O C50% Max

Capsules & Sensitive Materials25-27O C50% Max

Other products

30O C

70% Max

(b) Laboratory

Instrument room & Microbiology room25-27O C50% Max

Chemical Laboratory

28-30O C70% Max

Quarantine & Control Sample Room

25-27O C50% Max

Liquid Mfg. & Bottle Washing

28-29O C70% Max

Ointment & Lotions

25-27O C50-55%

TITLE: SOP FOR ENVIRONMENT MONITORINGPage : 03-03

Deptt.: PRODUCTION


Prepared by:





1. Record the result in the following formatDateAreaTimeLimitObservationRemarks

TITLE: SOP FOR REMOVAL OF SCRAP FROM PRODUCTION AREAPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Removal of Scrap form Production Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 All the scraps are collected in a polythene lined dust bin.

5.2 All scarp filled polythene bags in dustbin are taken to scrap dumping area.

6) PRECAUTIONS:

6.1All scraps must be checked by House keeping Supervisor to ensure that no printed packing material container or machine parts reach at the backyard.

TITLE: SOP FOR DISPOSAL OF EMPTY CONTAINERSPage : 01-01

Deptt.: PRODUCTION


Prepared by:





7) PURPOSE:To lay down a Procedure for Disposal of Empty Containers.



10) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.11) PROCEDURE:5.1 CORRUGATED BOXES

5.1.1 Ensure that the boxes/ containers are empty.

5.1.2 Fold the boxes, stuck and tie them.

5.1.3 Transfer them to scrap yard.

5.2 METALLIC CONTAINERS

5.2.1 Wash all the containers with sufficient quantity of tap water.

5.2.2 Transfer the containers to scrap yard.5.3 GLASS CONTAINERS

5.3.1 The glass scarp is sorted out in the Scarp Yard.

5.3.2 Containers are property checked for any left out material.

5.3.3 Cross mark on label of the corrugated box with black marking pan.

5.3.4 Do not use empty containers for storage of any other material.

5.3.5 Destroy the containers containing hazardous / corrosive material in presence of warehouse supervisor.TITLE: SOP FOR CLEANING OF GENERAL DRESSESPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning of General Dresses.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:All the dresses are cleaned at a single place under the supervision of the above-specified competent personnel.5.1 The collected dresses are further categorized as per their color and utilization and properly recorded in the log book available with the house keeping department.

5.2 All the unclean dresses are then segregated as per their color and use and entered in the log book prior to given for washing.

1) CLEANING PROCEDURE :6.1 The unclean dresses are washed by the washerman; he is instructed to wash colored and white dresses separately to avoid coloration of the white dresses.

6.2 The dresses are first observed for any oil spot or other chemicals to be removed with solvent namely IPA / Ethanol, prior to washing.

6.3 The above treated dresses are then dipped in a soap solution at a temperature between 40 to 45OC and rotated for 30 to 35 minutes.TITLE: SOP FOR CLEANING OF GENERAL DRESSESPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6.4 The above treated dresses are then squeezed and dipped in a drum of fresh water and again rotated for 30 minutes and with another change of fresh water these are placed for spinning stage.

6.5 Drying of the washed dresses are carried either by centrifugal method of by drying in a current of warm air. Drying in direct sunlight is strictly avoided.

6.6 After complete drying of the dresses it goes under ironing.

6.7 The dresses are daily cleaning as per the above procedure.

6.8 All the cleaned dresses are then received and recorded in the Logbook.

6.9 The cleaned dresses are then segregated as per their colour and requirements and kept in the appropriate cupboard making entry in the logbook.

6.10 The above cycle is continuously monitored and dresses are issued to each department by Signing in the logbook.

6.11 The change in the above process is validated by the concerned Department / Personnel only.TITLE: SOP FOR CLEANING AND SANITATION OF GENERAL AREA PRODUCTION BLOCKPage : 01-03

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Removal of Scrap form Production Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) FREQUENCY:Daily Schedule.

6) PROCEDURE:6.1 Pick up the trace materials from floors.

6.2 Empty waste bins and reline with plastic bags when necessary.

6.3 Wash sink and waste pipe using 0.1% Teepol solution in water and wipe dry.

6.4 Wash interior surface of commode bowl using bowl cleaner solution with a bowl mop. Wash exterior surface of bowl seat using 0.1% Teepol solution in water.

6.5 Damp mop all accessible are using lint free or rubber lined handle mops initially with a 0.1% Teepol solution in water then with plain water and finally with a disinfectant solution.

Bucket 1 To squeeze out the dirty water from mop.

Bucket 2- To Contain clean water for rinsing the mop.

6.6 Use two bucket system.

6.7 Dispose off the used water promptly.

6.8 Allow the floor to dry up.

6.9 Flush out the drainage channel after removing any solid debris.TITLE: SOP FOR CLEANING AND SANITATION OF GENERAL AREA PRODUCTION BLOCKPage : 02-03

Deptt.: PRODUCTION


Prepared by:





6.10 Wipe the surrounding area with a mop soaked in disinfectant solution.

6.11 Wash hands before carrying out any other activities.

6.12 Rotate the disinfectant to be used on daily basis and record the same in daily cleaning.

6.13 Mop up any spillages as soon as it occurs.

6.14 Carryout the cleaning operation as and when necessary to ensure the aera as clean and hygienic.

6.15 Fill the daily cleaning and sanitation record and get it Signed.

Weekly Schedule:1. Clean the wall using sponge impregnated with 0.1% Teepol solution in water.

2. Wipe down the handrails, stairways with an approved disinfectant solution.

3. Dedust all the shelves, floors and walls of change rooms, the storage and weighting area using a sponge.

4. Damp wipe all surfaces with 0.1% Teepol solutions in water after moving out any movable equipment such as container, weighing balance.

5. Damp wipe the accessible parts of intercom with sponge or cloth.

6. Damp wipe the doors, push plates, view panels and glasses with a spray of aerosols cleaner (Colin) and wipe dry.

7. Dedust exhaust fan, light fixer with sponge or cloth.

8. Damp wipe all other fixer with a sponge or cloth using 0.1% Teepol solution in water.

9. Hose down the passages with plenty of water. Flush out the water.TITLE: SOP FOR CLEANING AND SANITATION OF GENERAL AREA PRODUCTION BLOCKPage : 03-03

Deptt.: PRODUCTION


Prepared by:





Monthly Schedule

1) Wash waste bin with a disinfectant solution.

2) Apply the floor finish on clean and dry floor and rub it to polish.

3) Clean wipe the light diffuser and U.V. Light tube with a wet cloth.

4) Clean wipe the light switches with I.P.A.

TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCEPage : 01-02

Deptt.: PRODUCTION

SOP No.: SPD/16Effective Date: 15-07-2007Revision No.:Review Date: 14-07-2009

Prepared by:





1) PURPOSE:To lay down a Procedure for Calibration and Operation of Weighing Balance.




6) CALIBRATION :6.1 Switch off the electric supply to the balance, in case of an electric balance.

6.2 Clean the pan/ platform of the balance with a brush. If required cleaning is done with clean cloth dipped in 0.1% Teepol solution followed by clean water.

6.3 Check the level of balance and ensure that the balance is properly leveled.

6.4 Select the standard weights for various weighing balance based upon the capacity of balance to be calibrated.

6.5 In case of electronic balance switch ON the balance, adjust the balance whether electronic or mechanical to zero. Place standard weight s one by one on the platform/ pan. Record the rading in respect calibration record. These records are available at weighing station.

6.6 Check that the observed weights are within the limits, as given in this SOP.

6.7 If the error is more than acceptable limits, the error is rectified before the balance is to be used.

6.8 Do not use the balance if the error is not rectified. Inform the Production Executive and call the Service Engineer.Balance CapacityStandard WeightStandard WeightAcceptable Limit

200 gm1.00 gm10 gm+0.1 % max.

6 kg400 gm5 kg.+0.25% max.

60 kg5 kg.10 kg.+0.25% max.

100 kg5 kg.50 kg.+0.25% max.

TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCEPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6.9 Selection of standard weights for interpretation of data is given below :-7.0 OPERATION:-7.1 In case of electronic balance, switch OFF electric supply to the balance.

7.2 Clean the pan of the balance with brush. If required, Teepol solution 0.1% followed by D.M. water and wipe dry with clean cloth.

7.3 Level the balance property.

7.4 Keep pallets and stainless steel containers near the balance.

7.5 In case of electronic balance, switch ON the power supply.

7.6 In case of electronic balance, press the ON switch on the digital control and wait till it indicates ZERO. In case of mechanical balance check ZERO reading.

7.7 Balance set to zero, if any error is observed.

7.8 Place the material on the balance platform / pan by one and check. Check the weights against requisition slip and batch production record.

7.9 Material tags are tally with the details on Batch Production Record. Checks tally the name of material, A.R. No., gross weight, tare weight and net weight of material.

TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING MACHINEPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Manual Capsule Filling Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1) CLEANING :5.1.1 Loosen the bolt of the capsule filling machine.

5.1.2 Dismantle all the supporting plates & lock plates from the machine and dip in water.

5.1.3 Remove the powder from the machine by the Nylon brush. Transfer all parts to washing area. First clean with 0.1% Teepol solution or equivalent soap solution by moping with non woven cloth.

5.1.4 Wash the machine with raw water.

5.1.5 Rinse with DM water.

5.1.6 Dry the machine.

5.1.7 Send a wash water sample for analysis of previous product to Q/A, Q/C Department.

TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING MACHINEPage : 02-02

Deptt.: PRODUCTION


Prepared by:





5.2) OPERATION:-5.1.1 After receiving the QC report fix a label. Ready For Use.

5.1.2 After getting QC report, reassemble the capsule machine for filling of next batch (Product).

5.1.3 Fix the Guide Plate on the machine.

5.1.4 Weigh qty. of powder to be filled for 300 capsules. Put the powder on the capsule magazine, spray the powder by a plastic made spreader.

5.1.5 Press the top plate on filled magazine.

5.1.6 Load the caps part of the capsules, and lock the plate by pressing with handle.

5.1.7 Loosen the lock bolt, remove the filled capsules.

5.1.8 Continue the same process, till the batch is finished.

5.1.9 Record the machine cleaning / operation in record. Format.

TITLE: SOP FOR CLEANING AND OPERATION OF BLISTER PACKING MACHINEPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Blister Packing Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:Cleaning5.1 Switch OFF the mains.5.2 Clean the blister packing machine with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.5.3 Remove the blister forming roller, ink device, hopper, chute, channel, plate ,sealing roller etc.5.4 Clean them with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.5.5 Rinse with raw water, and finally with DM Water.5.6 Clean the conveyor belt with the Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.5.7 Rinse with raw water, and then rinse with DM Water.5.8 Close the valve of compressed air, raw water supply line.5.9 Proper oiling and greasing in the machine are necessary before installation of machine.5.10 After drying, reassemble the machine.TITLE: SOP FOR CLEANING AND OPERATION OF BLISTER PACKING MACHINEPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6. OPERATION :6.1 Before the starting of the machine check the sealing roller, forming rolls, guide track, chute, hopper etc.6.2 Open the valve of compressed air and raw water.6.3 Fill the ink pot with the ink, and fix the stores.6.4 Start the temperature heating element and roller forming switch.6.5 When temperature reaches at approx. 160OC, fix the blister/ PVC roll and printed aluminum foil of the required product.6.6 Now start the machine to check the forming cavity and sealing of blister strip.6.7 Load the hopper with tablets/ capsules for commercial packing.6.8 Check the sealing by Leak Test method.

TITLE: SOP FOR CLEANING AND OPERATION OF DOUBLE CONE BLENDERPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Double Cone Blender.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:CLEANING: 5.1 Switch OFF the mains of Cone Blender.

5.2 Loosen the bolt/ clamp of the cone blender.5.3 Remove the gasket and top of the mouth from the cone blender, dip in a soap or Teepol solution (0.05%).

5.4 Clean the cone blender with 0.1% Teepol solution by moping with non woven cloth.

5.5 Rinse with raw water, finally clean with DM Water.

5.6 Mop the external parts of the cone blender/ frames by the non woven cloth.

5.7 After complete cleaning of cone blender send wash water sample for analysis.TITLE: SOP FOR CLEANING AND OPERATION OF DOUBLE CONE BLENDERPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6. OPERATION:-6.1 After getting the wash water report, fix a label MACHINE IS READY FOR USE.6.2 Switch ON the mains.6.3 Add the batch (Powder) for mixing.6.4 Close the top lid, fitted with gasket.6.5 Tight the bolts/ clamps.6.6 Start the machine for mixingCAUTION: Before starting of the machine, keep distance at least 3 ft. from the machine to

avoid the accident.

TITLE: SOP FOR CLEANING AND OPERATION OF DRY FILLING MACHINEPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Dry Filling Macnine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1) CLEANING:-5.1.1 Switch OFF the mains.

5.1.2 Loosen the bolt, remove the lock of hopper of dry syrup filing machine.

5.1.3 Dismantle the auger & nozzle.

5.1.4 Loose the weight variation adjustment lock.

5.1.5 Dip all the dismantled parts in 0.1% Teepol solution.

5.1.6 Mop the dismantled parts by non woven cloth.

5.1.7 Rinse with raw water till frothing is removed.

5.1.8 Clean the external machine parts and body with DM Water by wet moping and dry the machine.

5.1.9 Finally rinse with DM Water and send a sample of wash water to the Q.A. department.TITLE: SOP FOR CLEANING AND OPERATION OF DRY FILLING MACHINEPage : 02-02

Deptt.: PRODUCTION


Prepared by:





5.2) OPERATION

5.2.1 After getting the result form Q.A. department fix a label MACHINE IS READY FOR USE.

5.2.2 Reassemble all the dismantled parts of the machine i.e. auger, weight wheel, hopper etc.

5.2.3 Add the powder/ granules of next batch; switch ON the mains.

5.2.4 Start the machine and check the weight of fixed quantity of each bottle.

5.2.5 Check the adjusted weight for at least 10 bottles of dry syrup.

5.2.6 Now start the production till the batch is finished.

5.2.7 Checking of weight variation of filled dry syrup bottles is done after every 30 minutes.

5.2.8 Record pertaining to cleaning, operation and weight variation is recorded in format.

TITLE: SOP FOR CLEANING AND OPERATION OF ROPP CAP BOTTLE SEALING MACHINEPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of R.O.P.P. Cap Bottle Sealing Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 CLEANING:-5.1.1 Switch OFF the mains.

5.1.2 Clean he machine with Teepol solution (0.1%) or eq. soap solution.

5.1.3 Dismantle the sealing die. Clean with the dry cloth dipped in diesel to avoid the rust from environment.

5.1.4 Clean the footrest with dry cloth by moping.

5.1.5 Apply the grease / Lubricant oil to the axle of the footrest and lever of sealing die guide.

5.1.6 Reassemble the die. Finally clean the machine with dry cloth.

5.2 OPERATION:-5.2.1 Adjust the height of bottle with ROPP cap dry inching method.

5.2.2 Check the sealing of 10 dry syrup bottles for good quality of sealing.

5.2.3 Adjust the guide of the bottle pressing plate / lifting plate with sealing die.

5.2.4 Now start the production till the batch is finished.

5.2.5 Record the total cleaning and operation in record book format.

TITLE: SOP FOR DECARTONING OF CONTAINERS AND CLOSURESPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Decartoning of Containers and Clousres.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 General Rules :

5.1.1 All filling materials must be requested from the warehouse well in advance. These are supplied in their shipping boxes or shrink wrapped trays. No shipping box is slowed in clean area.

5.1.2 All excess material supplied which is not used is returned to warehouse. No unnecessary material is allowed to accumulate in clean area.

5.1.3 Tearing off paper in the clean area is not permitted.

5.1.4 All wastage is deposited in the dustbins provided.

TITLE: SOP FOR CONTROLLING MICROBIAL CONTAMINATION (Ointment section)Page : 01-01Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Controlling Microbial Contamination (Ointment Section).



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:Controlling Microbial Contamination:- Producing product of 100% efficacy by adopting following procedures:a)Compounding room cleans up: - Moping the floor and working table with hot 0.1% Teepol solution

Rinse the floor and working table with hot water.

Keep personnel traffic to a minimum.

b)Compounding equipment cleans up:- It is done just after completion of current batch

Clean the melting and compounding vessel with hot 0.1% Teepol solution.

Scrub the vessel, cover, agitator, scrapper with nylon scrubber to remover trace of the pervious product. Disassemble the other equipment which comes in to content with product and clean with hot 0.1% Teepol solution and rinse with DM water and sanitize with 70% IPA.

If manufacturing equipment is stored for more than three days it must be resanitize before Use.

c)Filling equipment clean up and sanitization:- Dissemble all parts that come in contact with product.

Scrub all contact parts with 0.1% hot Teepol solution

Now finally rinse with DM waterTITLE: SOP FOR LINE CLEARANCE (PACKING)Page : 01-01Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Line Clearance (Packing).



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Packing line is cleared after every product changeover.

5.2 All unpacked goods are packed in one container and properly labeled. It is send to quarantine for storage till next packing schedule.

5.3 All rejected goods, if recoverable, are properly labeled and send to recovery quarantine.

5.4 All intact packing materials, boxes, shipper carton, labels are properly counted and tied and returned to packing store.

5.5 All torn / rejected packing material and rejected goods are shifted to scrap yard in a polythene bag for disposal.

5.6 The finished goods are accounted for and transferred to Finished Goods stores along with finished good transfer slip.

5.7 The packing belt / tables are cleaned both from top and floor and waste is collected in dust bin.

5.8 The packing area/ belt/ table are cleaned and mopped before starting packing of next product / batch.

5.9 Production Manager / Q.A. Manager jointly conduct line clearance operation.

5.10 Line clearance operation is recorded in prescribed format and duly signed by Q.A. Manager/ Production Manager.TITLE: SOP FOR VISUAL INSPECTIONPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Visual Inspection.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Test and release filled bottle of the product received from quarantine area to visual inspection area.

5.2 Depute the visual inspection team for proper checking of fiber / glass / black white particles and any foreign matter.

5.3 Check the proper sealing of bottle.

5.4 The complete visual inspection team is divided into 2 group of expert team.

5.5 Visual inspection is done by unaided naked eye.

5.6 The percentage of rejection found is to be recorded in flow sheet and register.

5.7 The visual inspection team personnel are needed maintained accordingly to ensure the proper checking of foreign matter.

5.8 Rotation gap between one group to other group is two hourly.5.9 Finally calculate the percentage of rejection of complete batch and transfer to packing department with details bearing product name, B. No. Size, D/M, D/E.

TITLE: SOP FOR BATCH CODINGPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of R.O.P.P. Cap Bottle Sealing Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:All the dosage forms are properly categorized with different codes explaining the details of each individual batch which is prepared and approved by the authorized personnel only.A.Name of the authorized personnel

B.Details of the dosage forms for which batch coding requires.

B1Capsules/ Tablets

B2Dry Syrup

B3Topical Creams and Ointment.

C.Procedure of batch coding.

D1Batch Code have minimum 3-4 digits.

D21st and 2nd place are denote product code as per attached list e.g.

D33rd and 4th place are denote serial No. of batch e.g. 02 denotes 2nd

batch of the year of that particular product.TITLE: SOP FOR REPROCESSING OF RECOVERYPage : 01-01

Deptt.: PRODUCTION


Prepared by:





6) PURPOSE:To lay down a Procedure for Reprocessing of Recovery.



9) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.10) PROCEDURE:5.1 The recoverable bottle of the different batches are collected and reported in new flow sheet with a batch no., batch size and expiry date must be mentioned of the first batch of recovery.

5.2 The bottle are collected and transferred in a clean area and reopened and solution is collected in a S.S. closed container.

5.3 Nitrogen flushing of the recovered solution is done till the batch is filled.

5.4 Recovered bulk solution is sent for testing to check the pH, assay and other tests as required.

5.5 After getting the approval from the Q.A. Department recovered solution is filtered through sterile membrane filter in a sterile filling vessel.

5.6 Filtered solution is filled as a new batch and new Batch No. M/D, E/D, is mentioned in each and every stage.

5.7 The expiry of the new batch is the expiry of the oldest recorded batch.

5.8 Recovery details are to be recorded in the presented format of the Batch Record.

TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING)Page : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Leak Test for Capsules / Tablets (Strip and Blister Packing).



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 A sample of 4 strips (pr equivalent to 40 pockets, whichever is higher) to be collected from the machine at the time of start up and then at an interval of 1 hours.

5.2 Place the sample into a vacuum dessicator containing enough water to cover the sample with at least one inch of water (measured from the top surface of package). Use a metal grid or screen to hold the sample submerged.

5.3 Close the dessicator and slowly apply 10 inches (25 cm) of vacuum as read on a vacuum gauge, taking between 30 seconds and one minute to raise the vacuum. Hold under vacuum for 3 minutes. Present the vacuum line for 10 inches of vacuum by means of valve.

5.4 Slowly release the vacuum and remove the samples.

5.5 Carefully dry the samples with tissue paper or soft cloth.TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING)Page : 02-02

Deptt.: PRODUCTION


Prepared by:





5.6 Examine all pockets for evidence of leakage, i.e. water.

5.7 If one pocket shows evidence of leakage, reject the sample, stop the line, and immediately notify the packing line supervisor so that corrective action may be taken.5.8 After adjustment of the sealing machine, select another representative set of samples, and repeat the leak test. If no leakage is detected, the line may be restarted. If leakage of any sample is still evident, adjust the machine and perform re-testing until the process is demonstrated to be under control.

5.9 Record the results of all tests in the packing record, indicating the time tested, the sample size, the number of leaking samples, found, the corrective action taken and the result of further testing.

TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINEPage : 01-03

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Capsule Loader Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE: FOR PRODUCT TO PRODUCT CHANGEOVER:1.Dedusting external surfaces:-

Use clean nylon brush and wipe with clean dry lint free duster.

2.Dismantling Remove:-

(a)Back and front cover.

(b)Empty capsule hopper.

(c)Magazine followed by pusher plate and raceway.

3.Cleaning of parts:-

Clean the above parts by washing with 0.1% Teepol solution and scrubbing with soft nylon brush. Rinse with jet of potable water followed by rinsing with D.M. water. Clean loading platform with wet duster. Clean back and front cover and empty capsules hopper using clean dry lint free duster.TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINEPage : 02-03

Deptt.: PRODUCTION


Prepared by:





4.Drying:-

The cleaned parts as mentioned in step 3 are wiped and dried using clean dry lint free duster.

5.Assembling:-

Reassemble all the parts of the machine carefully checking the correctness of assembling.

Note:5.1 Fix the cleaned label.

5.2 If the cleaned loader is not used within 24 hours after cleaning or there are sign of dust or powder settled on loader, then wipe the body by using a freshly laundered lint free duster.

6. PROCEDURE FOR BATCH TO BATCH CHANGEOVER:-6.1 Empty out the hopper.

6.2 Remove back and front cover.

6.3 Remove empty capsules from loading platform by bursh.

6.4 Dry-clean the loader with clean dry lint free duster.

CAUTION: In case of any abnormal sound from machine during its operation, stop the machine and report to maintenance.TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINEPage : 03-03

Deptt.: PRODUCTION


Prepared by:





7. ASSEMBLING:-7.1Assemble clean and dry accessories in following manner.

7.2 Raceway along with pusher slide and magazine

7.3 Front and back cover.

7.4 Empty capsules hopper.

8. OPERATION:-8.1 Ensure that all parts of machine are cleaned as per standard procedure.

8.2 Load empty capsules in hopper.

8.3 Switch on mains of machine.

8.4 Fit capsules loading plate on loading table.

8.5 Push loading plate inside by turning front knob in clockwise direction. Push the green button to load capsules.

9. DISMANTLING:-9.1 Remove the front and back cover.

9.2 Remove the empty capsules hopper.

9.3 Remove magazine followed by pusher plate and raceway. Clean machine and dismantled parts as per standard cleaning procedure.

10. CAUTIONS: Switch off the electrical mains of the machine.

TITLE: SOP FOR CLEANING & OPERATION OF DEHUMIDIFIERPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Dehumidifier.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1) Switch off the mains

5.2) Clean all surfaces of instruments by clean dry cloth, then with wet cloth dipped in 0.1% Teepol solution.

5.3) Clean it again with next dry lint free cloth.

5.4) Take out the Pre-filter and wash it with 0.01% Teepol solution and finally with DM Water.

5.5) Dry pre-filter with the dry heat blow.

5.6) The water storage SS tank is thoroughly washed and cleaned with 0.1% Teepol solution and finally with DM Water.5.7) 1st ice formation takes place on the inner surface of Pre-filter. Get it cleaned by spraying hot DM Water spray and finally get it dried by blowing warm air current.

TITLE: SOP FOR CLEANING & OPERATION OF DEHUMIDIFIERPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6. OPERATION:-6.1 Ensure that all parts of machine are cleaned as per standard procedure.

6.2 Check the manufacturing area from the point of exposures and disturbances.

6.3 Switch on mains of electricity supply after all setting of its implements, if area is found perfect.

6.4 Keep it ON before one and half hours of the start of working.

6.5 Check relative humidity percent of the area half on hourly.

6.6 After getting the desired temperature and relative humidity percentage, production conducted scientifically.

6.7 Temperature regulation of the working area is to be controlled by air conditioning procedure.

6.8 Record all valuable data in record format.

CAUTION: In case of any abnormal sound or disturbance from machine during operation, stop it and report to maintenance for overhauling.

TITLE: SOP FOR CLEANING & OPERATION OF STRIP PACKING MACHINEPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Strip Packing Machine.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 CLEANING:5.1.1 Switch OFF the mains.

5.1.2 Clean the strip-packing machine with Teepol solution (0.1%) or eq. soap solution by nylon cloth / foam.

5.1.3 Remove the strip forming roller, ink device, hopper, chute, channel, plate, sealing roller etc.

5.1.4 Clean them with Teepol solution (0.1%) or eq. soap solution by nylon brush/ brass brush.

5.1.5 Rinse with raw water, and finally with DM Water.

5.1.6 Clean the conveyor belt with the Teepol solution (0.5%) or eq. soap solution by nylon cloth / foam.

5.1.7 Rinse with raw water. Then Rinse with DM Water.

5.1.8 Proper oiling and greasing in the machine is necessary before installation of machine.

5.1.9 After drying, reassemble the machine.TITLE: SOP FOR CLEANING & OPERATION OF STRIP PACKING MACHINEPage : 02-02

Deptt.: PRODUCTION

SOP No.: 31Effective Date: 15-07-2007Revision No.:Review Date: 14-07-2009

Prepared by:




Sign..Sign..Sign......Sign...

5.2 OPERATION :

5.2.1 Switch OFF the mains.

5.2.2 Before the starting of the machine, check the sealing roller, forming rolls, guide track, chute, hopper etc.

5.2.3 Fill ink with the inkpot, and fix the stereos.

5.2.4 Start the temperature-heating element and forming roller switch.

5.2.5 When temperature reaches at approx 120OC. fix the aluminum foil of the required product.

5.2.6 Now start the machine to check the forming cavity and sealing of strip.

5.2.7 Load the hopper with capsules/ tablets for commercial packing.

5.2.8 Check the sealing of strip by leak test method.

TITLE: SOP FOR CLEANING & OPERATION OF SIFTERPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning and Operation of Sifter.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:As soon as the shifting process is over, dismantle the following parts:a)SS feed hopper

b)SS frame, holding the sieve in place

c)SS wire mesh sieve.

5.1 Remove all the residual powder adhering to the above mentioned articles with the help of a nylon brush.5.2 Wash these articles with hot water.5.3 Wash these articles with 0.1% Teepol solution.5.4 Clean these articles with running water to remove all traces of detergent.5.5 Drain off all the water and dry all the articles.5.6 Clean the exterior of the sifter stand and motor assembly with the help of a lint free wet cloth.5.7 Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter stand.5.8 Assemble all the cleaned / dried articles from step 5 on the Sifter stand frame.TITLE: SOP FOR CLEANING & OPERATION OF SIFTERPage : 02-02

Deptt.: PRODUCTION


Prepared by:





6. Affix a clean label giving following information:

a) Name of the equipment.

b) Name of the last product shifted.

c) Name of the operator who cleaned the equipment.

d) Date of cleaning.

e) Supervised by

7. OPERATION:

7.1 Before starting the shifting operation, ensure that the machine is clean.7.2 Put appropriate quantity of material to be shifted on the SS mesh sieve using cleaned SS scoops.7.3 Tie polybags kept in SPD/Plastic drums to the outlet of Sifters with the help of twine.7.4 Switch ON the machine.7.5 After the drum is filled to 80-90% capacity, tie the polybag, close the lid of drum and fix identification label on it showing the Name, Batch No. & Batch Size of the product.7.6 Repeat steps 2 to 5 until the shifting process is completed.7.7 After the operation is over, fix To be cleaned label on the machine.7.8 Clean the Sifter as per SOP.

CAUTION: Please clean before use.

TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STOREPage : 01-03

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Handling of Finished Products in Store.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Goods laying in the factory goods distribution store.

5.2 If the product has remained in the above stores for a longer period then on the request of store In-Charge, the goods are sampled and subjected to stringent inspection and required analysis by Q.C. Department.

5.3 Random sampling is carried out by the in process supervisor in presence of Q.C. officer in accordance with the statistical Production & for this purpose normal level of sampling to be done.

5.4 Samples collected from the stores and sent to the Q.C. Department for analysis Within 15 days along with format test reports are reported. The operation on the suitability or otherwise of product for distribution is also forwarded along with analysis report by Q.C. Manager to the store In-charge.

5.5 If the product is found satisfactory by Q.C. department it can be released for distribution.

5.6 If the results are unsatisfactory the product returned by the stores in charge to the factory for reprocessing and repacking if required, immediately after the receipt of the Q.C. report.

5.7 If the quality of the product during storage is found to have deteriorated / degraded to an extent that it is unfit for re-processing the same is destroyed with the permission of production director/ production manger in presence of representative of Q.C. department certificate to this effect in triplicate and Signed by the store in charge and Q.C. manager issued, one copy to be retained by the Signing authorities and third copy to be filled in the BPR, of concerned batch of the product.TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STOREPage : 02-03

Deptt.: PRODUCTION


Prepared by:





5.8 The following particulars are entered in the register maintained by stores:-5.8.1 Serial No.

5.8.2 Name of the product.

5.8.3 Date of Mfg. and Date of Exp.

5.8.4 Quantity involved.

5.8.5 Randomly sampled Quantity

5.8.6 Stock in hand.

5.9 The following particulars are entered in the register maintained by Q.C.

Department:-5.9.1 Serial No.

5.9.2 Name of the product.

5.9.3 Date of Mfg. & Date of Exp.

5.9.4 Sample received from

5.9.5 Date of receipt

5.9.6 Date of analytical report

5.9.7 QA Managers opinion

5.9.8 Quantity destroyed.

5.9.9 Date of destruction of stocks.

5.9.10 Signature of Q.C. Manager.

5.10 Goods lying in branch ware /house company depots if any :-5.11 Products may be damaged during transport. It can be in the form of breakages without damage to content or physical damage. Base on the type and extent of damage. Branch or depot in-charge is decide the action. The inchange samples the product as per sampling plan and send for Q.C. Department.TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STOREPage : 03-03

Deptt.: PRODUCTION


Prepared by:





5.12 Goods lying in the transporters go-down or received back by the depot from market.

5.13 The product inspected for physical damage, if any on receipt from the transporters go-down by the stores in-charge at the branch depot, based on the type and extent of damage. The branch personnel are further action.

5.14 If the product needs any re-dressing or reprocessing the same is subjected to treatment as above.

TITLE: SOP FOR PACKING OPERATIONPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Packing Operation.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 After issue of packing material from warehouse, check for identity and quantity.

5.2 Store printed material properly

5.3 Before starting of operation the labels and cartons are checked for any defect.

Check identity of product & Quantity of product before starting of packing operation.

5.4 Before starting fresh batch all material required are brought and kept at relevant place only.

5.5 Get the line clearance.

5.6 After packing is over, inform Q.A. for their check.

5.7 Deliver the goods to the warehouse only on receipt of final approval from Q.A.

5.8 Disposal of excess labels, cartons and records is done as per SOP No. SPD/12.

5.9 Clean up the area at the end of days work.

TITLE: SOP FOR CLEANING OF PASTE KETTLEPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Cleaning of Paste Kettle.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 The General Utensils like S.S. Container, S.S. Scoops, and S.S. Trays etc. are washed with water.

5.2 Wash with liquid soap or detergent with gentle rubbing. Then wash with fresh water until the detergent foam is completely washed out.

5.3 Finally wash with DM water and get wash utensils checked from the Q.C. lab.

5.4 Mop with dry, clean cloth.

TITLE: SOP FOR GENERAL CLEANING OF EQUIPMENT IN MANUFACTURING AREAPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for General Cleaning of Equipment in Manufacturing Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Check electrical terminals for insulation and soundness of terminal connections. Check soundness of electrical switches and its contacts.

5.2 At the end of the shift the equipment is cleaned.

5.3 Clean all the machine parts using potable water. Then wash with 0.1% Teepol solution. Then rinse with potable water and then rinse with D.M. Water.

5.4 Finally rinse with D.M. water and send the wash water to Q.C. Department for analysis.

5.5 Wipe dry the surfaces, using clean dry cloth.

5.6 After getting O.K. report from Q.C. Department, put a tag on machine CLEAN & READY FOR USE.

TITLE: SOP FOR ADVERSE HEALTH CONDITION OF PERSON IN MANUFACTUEING AREAPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Adverse Health Condition of Person in Manufacturing Area.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 The people who are sick & ill or suffering from any disease are not permitted in production area.

5.2 The production Deptt. allows sick leave to sick person.

5.3 If any person feels discomfort in the production area or feel ill then inform immediately to concern supervisors / in-charge.

5.4 As a fixed policy of organization, the people are shifted outside the production area under medical aid.

TITLE: SOP FOR INTERNAL LABELING DURING QUARANTINE, STORAGE AND PROCESSINGPage : 01-02

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Internal Labeling during Quarantine, Storage and Processing.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Paste Material under Test printed yellow sticker on all the containers, of that material, which are under test.

5.2 Paste Approved slip printed green sticker on the entire container, of those material which are Tested by Q.C. Deptt.5.3 Paste Sampled printed sticker on those containers, whose content are sampled.

5.4 Paste Rejected printed red sticker on those containers, which contain rejected material.

5.5 Paste the following sticker on containers which are under operation.TITLE: SOP FOR INTERNAL LABELING DURING QUARANTINE, STORAGE AND PRICESSINGPage : 02-02

Deptt.: PRODUCTION


Prepared by:





Sticker3.3 IDENTIFICATION SLIP

1.Name of Product ..

2.Batch No.

3.Batch Size

4.Mfg. Date..

5.Exp. Date

6.Remarks

Signature

TITLE: SOP FOR RECEIPT OF PACKING MATERIAL IN PRODUCTIONPage : 01-01

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Receipt of Packing Material in Production.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE:5.1 Prepare requisition slip for the packing material.

5.2 Check and certify that the requisition slip is correct in all respect and get it authorized from production manager.

5.3 Deposit in stores for issuing the packing material.

5.4 Receive the issued material through the packing store material gate of production block.

5.5 Physically check and count all packing material received against requisition slip.

5.6 Acknowledge the receipt of material on requisition slip and file the departmental copy of BPR.

5.7 Stock the issue quantities properly in a manner to avoid damage due to over loading or fall down.

5.8 Store the received labels in cupboard and other printed packing components in a locked room. Restrict the access to this area.

5.9 Segregate the similar looking packing components.

5.10 Store the adhesives in tight container.

TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ EXPIRED/ UNUSABLE MATERIALSPage : 01-03

Deptt.: PRODUCTION


Prepared by:





1) PURPOSE:To lay down a Procedure for Disposal and Salavage of Rejected / Expired / Unusable Material.



4) SCOPE:The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal.5) PROCEDURE: The procedure mentioned has deals with three categories of unusable materials:-5.1)Rejected Material:a)Which does not confirm the stipulated standard?b)Rejection during processing to store.

c)Final product which fails to meet the standard.5.2) Expired Materials: Input materials or finished product which has lost its

credential due to non-usage for a period of over the years.5.3) Unusable Materials:a)Information of such items, which have become obsolete due to change of process / packing materials, which have lost its physical / chemical or biochemical properties.b)All rejected, expired and unusable materials are pasted with red stickers, so that they can be identified and are physically separated from the other materials.c)These materials are kept either in its original packing or in double poly bags duly knitted or sealed and bearing a sticker (red) with following informations.TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ EXPIRED/ UNUSABLE MATERIALSPage : 02-03

Deptt.: PRODUCTION


Prepared by:





RED COLOURED STICKER OF REJECTED MATERIALS

SARTHAK BIOTECH Pvt. Ltd.,

198/A, Sector-3, HSIIDC, KARNAL-132 001

D.L. No. : 619 B (H) & 977 OSP (H)

REJECTED

Pack No.______________

Raw Material___________________________________Batch No.______________________________________Date of Mfg.____________________________________Date of Exp.____________________________________Qty.___________________________________________Mfg. By________________________________________

Supplied By_____________________________________Test Date_______________________________________Analytical Report No._____________________________Control Ref. No__________________________________Failed Parameter_________________________________ Sig. of Q.C. Person

These materials are kept in a separate area in stores and periodically disposed off by either returning them to the supplier or sending them to scrap yard. From scrap yard the saleable items are sold through scrap dealers.

Other materials are destroyed by burning. Raw materials, Chemicals, powders are drained out after proper treatment.

The record of disposal is maintained at production/ stores department, in the form of registers.

TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ EXPIRED/ UNUSABLE MATERIALSPage : 03-03

Deptt.: PRODUCTION


Prepared by:





All the salvage by burning is authentic carSed by the following person.

1) In charge of either Production / Stores (concurred deptt.)

2) In-charge of Production.

The record of such

sop of production department

Documents

disposal operation

general cleaning of

cleaning of paste kettlespd35

operation of multimillspd44

cleaning of spray gunspd47

cleaning of polishing

operation of mass mixerspd55

disposal salvage