Process Validation Gonoshyastho

Gonoshasthaya Pharmaceuticals Ltd.
Research, Development & Quality Assurance Division

Name of facility : Gonoshasthaya Pharemaceuticals Ltd. Page of
Validation Protocol : Process validation
Title : Process Validation of G- Iron Tablet(Ferrous fumerate 200mg +
Batch No. : 113011, 113012, 113013 Folic Acid 0.350mg)BP
Batch size : 5,00,000 Tab.
Materials, Equipment, Documents
SOPs for normal operations of the process under test.

SOP list:
SOP for : 01. Cleaning of personnel before entering production area(No.-004)
02. Raw materials requisition/ received from store for production( No.-020)
03. Running of Balance ( 100kg/ 250kg )
04. Cleaning of process room(No.-005)
05. Labeling in difference stage of manufacturing(No.-003)
06. Batch process according to Manufacturing process sheet,QF/059-1
(No.-002)
07. Running of Gansons Planetary Mixer, PLM-350(No.-015)
08. Running of Alliance Fluid Bed Dryer (No.-017)
09. Running of Russell Sieving (20 mm Mesh(No.-049)
10. Running Gansons Multi Mill (1.5 mm)(No.011)
11. Running Gansons V-Blander (No.-017A)
12. Running of BB3B Compression Machine(No.019)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for : 01. Moisture determination ( No.-CL/27)
02. Analytical Specification of Gra. (QF/051B-A/001)
03. Determination of disintegration (No.-CL/25)
4 04. Determination of Friability (No.-CL/26)
05. Analytical Specification of finished product (QF/051B-B/029)
06. Running of UV-Visible Spectrophotometer (CL/017)
SOPs test specific to the validation study performed.
SOP list:
SOP for : 01. Sampling and testing of tablet for Process validation (No.CL/028-1)
02. Calibration of UV-Visible Spectrophotometer (QF/053A-2)
03. Calibration of Manesty Disintegration Test Unit (QF/053A-5)
04. Calibration of Friability test Machine (QF/053A-6)
05. Calibration of Moisture Analyser (QF/053A-1)
Validation Protocol : Process validation Page of
Title : Process validation of G- Iron Tablet
List of attached Data Record Forms
01. Manufacturing batch sheet/ procedure (QF/059-117)

02. Machine cleaning card (QF/019)
03. In-process Report, LOD (QF/051)
04. Short Laboratory report (QF/026)
05. Release tag for compression (QF/032)
06. Compression card (QF/045)
07. In-process Report, (QF/051)
08. Weight Control chart (QF/042)
09. In-process Quality Control chart (QF/051C)
10. Analytical report (QF/047)
11. Calculation and Statistical analysis.
12. Microbiological test report(QF/050)
13. Acceptance criteria vs test report.
14. Deviation and Process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Antacid Tablet(Aluminium Hydroxide
Dried Gel 250mg + Magnesium Trisilicate 500 mg) BP
Batch No. : 111001, 114002, 114003

SOP list:
(No.-002)
09. Running of Russell Sieving (20 mm Mesh(No.-049)
10. Running Gansons Multi Mill (1.5 mm)(No.011)
12. Running of BB3B Compression Machine(No.019)
SOP list:
04. Analytical Specification of finished product (QF/051B- )
SOP list:
Title : Process validation of G- Antacid Tablet

03. In-process Report, LOD (QF/051)
07. In-process Report, (QF/051)
Prepared by : ________________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Calcium Lactate Tablet
(Calcium Lactate BP 300 mg)
Batch No. : 119013, 119014, 119015
Batch size : 2,00,000

SOP list:
SOP for : 01. Cleaning of personnel before entering production area (No.-004)
02. Raw materials requisition/ received from store for production ( No.-020)
03. Running of Balance (No.-010)
04. Cleaning of process room (No.-005)
05. Labeling in difference stage of manufacturing (No.-003)
06. Batch process according to Manufacturing process sheet, QF/059-41
(No.-002)
07. Running of Gansons Sifter Machine, Mesh-20 (No.-049B)
08. Procedure for slugging (No.-054)
09. Running of Drum Mixer (No.-009)
10. Running Gansons Fitz mill (No.014)
11. Running of BB3B Compression Machine, Punch No.-10 (No.019)
SOP list:
02. Analytical Specification of Gra (QF/051B-A/009)

SOP list:
Title : Process validation of G-Calcium Lactate tablet

03. In-process Report,LOD (QF/051)
07. In-process Report (QF/051)
12. Microbiological test report (QF/050)
Verified by: _________________ Date: _____________

Title : Process Validation of G-Paracetamol 500mgTab.(Paracetamol BP)
Batch No. : 1110005, 1110006, 1110007

SOP list:
(No.-002)
07. Running of Gansons Sifter Machine, Mesh No.-20 (No.- )
10. Running of Russell Sieving, Mesh No.-14 (No.-049)
11. Running Gansons Multi Mill, Mesh No.-2.0 mm (No.011)
SOP list:
SOP list:
Title : Process validation of G-Paracetamol tablet

13. Deviation report.
14. Process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G-Albendazole 400mgTab.(Albendazole USP)
Batch No. : 113002, 113003, 113004

SOP list:
(No.-002)
07. Procedure for sieving of Material, Mesh No.-20 (No.- 002)
10. Running of Russell Sieving, Mesh No.-14 (No.-049)
11. Running Gansons Multi Mill, Mesh No.-2.0 mm (No.011)
12. Running Gansons V-Blander-500 (No.-017A)
13. Procedure for compression of tablet (No.- 003)
SOP list:
02. Analytical Specification of Gra. (QF/051-A/030)
04. Analytical Specification of finished product (QF/051-B/030)

SOP list:
Title : Process validation of G-Albendazole tablet

Verified by: _________________ Date: _____________

Title : Process Validation of G- Antihistamine Tablet
(Chlorpheniramine Maleate BP 4 mg )
Batch No. : 111002, 114003, 115004

SOP list:
(No.-002)
07. Procedure for sieving of Raw material, Mesh No.-20 (No.-052)
08. Running of Manesty-300 Mixer (No.-014)
09. Running of W-Fluid Bed Dryer (No.-017)
10. Running of Gansons Sifter Machine, Mesh-20 (No.-049B)
11. Running Gansons Fitz mill (No.011)
13. Procedure for compression of gra. (No.-018)
SOP list:
SOP list:
Title : Process validation of G-Antihistamine tablet

14. Deviation and process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Metronidazole Tablet
Batch No. : 1110005, 1110006

SOP list:
(No.-002)
07. Procedure for sieving of Raw material, Mesh No.-20 (No.-052)
08. Running of MP-90 Mixer (No.-013)
09. Running of W-Fluid Bed Dryer (No.-017)
10. Running of Gansons Sifter Machine, Mesh-14 (No.-049)
11. Running Gansons Fitz Mill, Mesh No.-2.0 (No.011)
13. Procedure for compression of Gra. (No.-018)
SOP list:
04. Determination of Disintegration (No.-CL/25)
05.Analytical Specification of finished product (QF/051B-B/026)
SOP list:
Title : Process validation of G-Metronidazole Tablet

13. Deviation report.
14. Process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Thiopentone Injection
(Thiopentone Sodium BP 500mg)
Batch No. : 115003, 116004, 118005
Batch size : 5 kg

SOP list:
04. Cleaning and sterilization of production area (Sterile) (No.-055)
06. Running of Ampoule/ Vial washing Machine (No.-021)
07. Running of Lytzen hot air Sterilizer (No.-022)
08. Running of Getinge programmable autoclave (No.-023)
09. Cleaning and ware of sterile dress (No.-056)
10. Running of Laminar air flow (No.- )
(No.-002)
12. Running of Dry vial filling sealing Machine (No.-043)
SOP list:
SOP for :
01. Analytical Specification of G-Thiopentone Injection (QF/051B-G/005)
2. Running of PH meter (No.-CL/013)
04. Sterility test (No.-MW/25)
SOP list:
SOP for :
01. Sampling and testing of liquid for Process validation (No.CL/028-3)
02. Calibration of PH meter (QF/053A)
04. Calibration of Getinge Programmable Autoclave (No.- )
Title : Process validation of G-Thiopentone Injection

03. Analytical report of bulk product (QF/045)
04. Release tag for filling (QF/032)
7. Analytical report (QF/045) (After filling )
8. Calculation and Statistical analysis sheet.
09. Checking of visible particle report(QF/029A)
12. Deviation report and process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Amoxicillin Injection
(Amoxicillin Sodium BP 500mg)
Batch No. : 114003, 115004, 118005
Batch size : 5 kg

SOP list:
(No.-002)
12. Running of Dry vial filling sealing Machine (No.-043)
SOP list:
SOP for :
01. Analytical Specification of G- Amoxicillin Injection (QF/051B-G/003)
SOP list:
SOP for :
1. Sampling and testing of dry vial Injection for Process validation
(No.CL/028-6)
Title : Process validation of G- Amoxicillin Injection

03. Analytical report of bulk product (QF/045)
10. Calculation and Statistical analysis sheet.
Prepared by: ________________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Chloramphenicol Eye/Ear Drop, 10 ml
(Chloramphenicol BP 5 mg/ml)
Batch No. : 1110004, 1111005, 1111006
Batch size : 50 Litre

SOP list:
11 07. Running of Getinge programmable autoclave (No.-023)
12 08. Running of Drop filling Machine (No.-044)
(No.-002)
SOP list:
SOP for :
01. Analytical Specification of G-Chloramphenical (QF/051B-L/001)
03. Running of Oven (No.-CL/006)

SOP list:
SOP for :
01. Sampling and testing of Eye/Ear Drop for Process validation (No.CL/028- )
Title : Process validation of G-Chloramphenical Eye/Ear Drop

03. Analytical report of (mixing stage) (QF/045)
7. Analytical report (QF/045) (After filling ) & Calculation of Statistical analysis.
Prepared by : ______________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Neomycin 0.5% Eye/Ear Ointment
(Neomycin Sulphate BP 5 mg/gm)
Batch No. : 812029, 812030, 812031
Batch size : 50 kg

SOP list:
13 07. Running of Getinge programmable autoclave (No.-023)
14 08. Running of MP-90 Machine (No.-013)
(No.-002)
12. Running of sterile ointment filling sealing Machine (No.-045)
SOP list:
SOP for :
01. Analytical Specification of G-Neomycxin ointment (QF/ )

SOP list:
SOP for :
01. Sampling and testing of ointment for Process validation (No.CL/028- )
Title : Process validation of G-Neomycin Eye/Ear ointment

03. Analytical report of (mixing stage) (QF/045)
8. Analytical report (QF/045) (After filling ) & Calculation of Statistical analysis.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Diazepam Inj. (Diazepam BP10 mg/2ml)
Batch No. : 119003, 119004, 119005

SOP list:
(No.-002)
12. Running of ampoule filling sealing Machine (No.-042)
SOP list:
SOP for :
01. Analytical Specification of G-Diazepam Injection (QF/051A-E/011)

SOP list:
SOP for :
01.Sampling and testing of liquid for Process validation (No.CL/028-3)
02.Calibration of PH meter (QF/053A)
03. Calibration of ampoule filling sealing machine (No.- )
Title : Process validation of G-Diazepam Injection

03. Cleaning of Bathroom, Coridor, Dress.
04. Check of Filtration Unit.
05. Short Laboratory report (QF/026) & Analytical report (QF/045)(Mixing stage)
06. Analytical report (QF/045)(After filtration)
08. Volume Control chart (QF/044)
Verified by: _________________ Date: _____________

Name of facility : Gonoshasthaya Pharmaceuticals Ltd. Page of
Title : Process Validation of G- Neostigmine Injection
(Neostigmine Methyl Sulphate BP 0.5 mg/ml )
Batch No. : 113002, 115004, 116005

SOP list:
(No.-002)
13.Inspection of ampoule/ vial (No. – 024)
SOP list:
SOP for :
01. Analytical Specification of G-Neostigmine Injection (QF/051B-F/003)
15 04. Running of UV-Visible Spectrophotometer (CL/017)
SOP list:
SOP for :
01.Sampling and testing of liquid for Process validation (No.CL/028-3)
02.Calibration of PH meter (QF/053A)
Title : Process validation of G-Neostigmine Injection

03. Short Laboratory report (QF/026)& Analytical report (QF/045)(mixing stage)
04.Analytical report (QF/045)(After filtration stage)
05. Release tag for filling (QF/032
08. Analytical report (QF/045) ) (After filling stage)
09. Calculation and Statistical nalysis.
10.Checking report (QF/029)
Verified by: _________________ Date: _____________

Title : Process Validation of G- Gentamycin Injection
(Gentamycin BP 80 mg/2 ml )
Batch No. : 113001, 113002, 114003

SOP list:
(No.-002)
13. Inspection of ampoule/ vial (No.- 024)
SOP list:
SOP for :
01. Analytical Specification of G- Gentamycin Injection (MW/026)

SOP list:
SOP for :
1. Sampling and testing of Inj./eye drop for Process validation (No.CL/028-3)
04. Calibration of Getinge Programmable Autoclave (No.-
Title : Process validation of G-Gentamycin Injection

04. Analytical report (QF/045)(After filtration stage)
09.Bacterial counting table (QF/ 070 ) .
10. Checking report (QF/029A)
Verified by: _________________ Date: _____________

Title : Process Validation of G- Pethidine Injection
(Pethidine Hydrochloride BP 100 mg/2 ml )
Batch No. : 114002, 116003, 118004

SOP list:
(No.-002)
13. Autoclave of ampoule after filling (No.- )
14. Inspection of ampoule/ vial (No.- 024)
SOP list:
SOP for :
01. Analytical Specification of G-Pethidine Injection (QF/051B-E/005)

SOP list:
SOP for :
Title : Process validation of G-Pethidine Injection

04.Analytical report (QF/045)(After filtration stage)
09. Calculation and Statistical nalysis.
10.Checking report (QF/029)
Verified by: _________________ Date: _____________

Title : Process Validation of G- Metronidazole Injection
(Metronidazole BP 5 mg/ ml )
Batch No. : 118031, 118032, 118033

SOP list:
(No.-002)
12. Running of vial filling Machine (No.-044)
13. Vial sealing machine (No. )
14. Autoclave of vial after filling (No.- )
SOP list:
SOP for :
01. Analytical Specification of G-Metronidazole Injection (QF/051B-M/001)
16 04. Running of UV-Visible Spectrophotometer (CL/017)
SOP list:
SOP for :
04. Calibration of vial filling sealing machine (No.- )
Title : Process validation of G- Metronidazole Injection

03. Cleaning of Bathroom, Coridor, Dress.
04. Check of Filtration Unit.
05. Short Laboratory report (QF/026) & Analytical report (QF/045)(Mixing stage)
06. Analytical report (QF/045)(After filtration)
07. Release tag for filling (QF/032)Analytical report (QF/045)
10. Analytical report (QF/045)(After filling & Autoclave)
Verified by: _________________ Date: _____________

Title : Process Validation of G- Lignocaine Injection
(Lignocaine Hydrochloride BP 20 mg/ml )
Batch No. : 112002, 112003, 113004

SOP list:
(No.-002)
12. Running of vial filling Machine (No.- 044 )
14. Inspection of ampoule/ vial (No.-024 )
SOP list:
SOP for :
01. Analytical Specification of G-Lignocaine Injection (QF/051-F/002)
SOP list:
SOP for :
03. Calibration of Vial filling machine (No.- )

Title : Process validation of G-Lignocaine Injection

03. Short Laboratory report (QF/026) & Analytical report (QF/045) (mixing stage)
04. Analytical report (QF/045) (After filtration stage )
05.Release tag for filling (QF/032)
08. Analytical report (QF/045)( After filling & Autoclave)
09. Checking report of visible particles (QF/029). ..
Verified by: _________________ Date: _____________

Title : Process Validation of G- Ketamine Injection
(Ketamine Hydrochloride BP 50 mg/ml )
Batch No. : 113003, 114004, 116005

SOP list:
(No.-002)
12. Running of vial filling Machine (No.- 044 )
14. Inspection of ampoule/ vial (No.-024 )
SOP list:
SOP for :
01. Analytical Specification of G-Ketamine Injection (QF/051B-E/013)
SOP list:
SOP for :
3. Sampling and testing of injection for Process validation (No.CL/028-3)
03. Calibration of Vial filling machine (No.- )
Title : Process validation of G-Ketamine Injection

03. Short Laboratory report (QF/026) & Analytical report (QF/045) (mixing stage)
04. Analytical report (QF/045) (After filtration stage )
05.Release tag for filling (QF/032)
08. Analytical report (QF/045)( After filling & Autoclave)
09. Checking report of visible particles (QF/029). ..
Prepared by : ________________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Paracetamol Syrup
(Paracetamol BP 120 mg/ 5 ml)
Batch No. : 113002, 114003, 115004 ;

SOP list:
(No.-002)
07. Cleaning of Vat (No.-026)
08. Running of Unisier Mixer (No.-029)
09. Cleaning of Sheets Filter (No.-030)
10. Running of bottle washing and drying Machine (No.-025)
11. Running of liquid filling Machine (No.-028)
SOP list:
SOP for :
01. Analytical Specification of G-Paracetamol Syrup (QF/051-C/004)

SOP list:
SOP for :
Title : Process validation of G-Paracetamol Syrup

06. Weight of liquid Control chart (QF/040)
09. Calculation and Statistical analysis
Verified by: _________________ Date: _____________

Title : Process Validation of G- Antacid suspension
( Aluminium Oxide 125 mg + Magnesium Trisilicate 500 mg/ 5 ml)
Batch No. : 114002, 114003, 115004 ;

SOP list:
(No.-002)
07. Cleaning of Vat (No.-026)
08. Running of Unisier Mixer (No.-029)
09. Running of bottle washing and drying Machine (No.-025)
10. Running of liquid filling Machine (No.-028)
SOP list:
SOP for :
01. Analytical Specification of G-Antacid suspension (QF/051-C/ )

SOP list:
SOP for :
Title : Process validation of G-Antacid suspension

06. Weight of liquid Control chart (QF/040)
Prepared by : _______________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Amoxicillin Dry Syrup, 125mg/ 5ml
(Amoxicillin Trihydrate BP)
Batch No. : 93062, 93063, 93064
Batch size : 5,000 Bottle

SOP list:
(No.-002)
07.Running of Multi mill, Mesh No.-0.5 mm (No.-011)
08. Running of Rahman Dryer (No.-057)
09. Running Cone blander (No.-008)
10. Bottle washing and drying (No.-025)
11. Running of Allide powder filling Machine (No.-007)
12. Running of Cap sealing machine (No.-051)
SOP list:
SOP for :
01. Moisture determination ( No.-CL/27)
02. Analytical Specification of G-Amoxicillin Dry Syrup (QF/051B-D/003)

SOP list:
SOP for :
1. Sampling and testing of dry syrup for Process validation (No.CL/028-4)
Title : Process validation of G-Amoxicillin Dry Syrup

03. Inprocess sheet for LOD (QF/051)
04. Short Laboratory report (QF/026) & analytical report (Bulk product) (QF/045)
06. Dry syrup weight control chart (QF/038)
Verified by: _________________ Date: _____________

Title : Process Validation of G- Amoxicillin Capsule( 500mg )
(Amoxicillin Trihydrate BP)
Batch No. : 116007, 1111008, 1111009
Batch size : 22,500 Capsules

SOP list:
(No.-002)
07. Filling of capsule (No.-058)
17 08. Running of Dott. capsule filler machine (No.-006)
SOP list:
SOP for :
18 02. Analytical Specification of G-Amoxicillin 500 mg capsule(QF/051B-H/008)

SOP list:
SOP for :
1. Sampling and testing of capsule for Process validation (No.CL/028-5)
Title : Process validation of G-Amoxicillin 500 mg Capsule

04. Assay report of bulk product
06. Capsule filling card (QF/048)
07. Capsule weight control chart (QF/038)
Prepared by : ________________
Verified by: _________________ Date: _____________

Title : Process Validation of G- Tetracycline Capsule( 250mg )
(Tetracycline Hydrochloride BP)
Batch No. : 119003, 119004, 119005
Batch size : 30,600 Capsules

SOP list:
(No.-002)
07. Filling of capsule (No.-058)
19 08. Running of Dott. capsule filler machine (No.-006)
SOP list:
SOP for :
02. Analytical Specification of G-Tetracycline capsule (QF/051B-H/003)

SOP list:
SOP for :
1. Sampling and testing of capsule for Process validation (No.CL/028-5)
Title : Process validation of G-Tetracycline Capsule

04. Assay report of bulk product
05. Release tag for filling (QF/032).
06. Capsule filling card (QF/048)
07. Capsule weight control chart (QF/038)
13.Deviation and Process validation report.
Verified by: _________________ Date: _____________

Title : Process Validation of G- Benzosal Ointment
(Benzoic Acid BP 6% + Salicylic Acid BP 3%)
Batch No. : 114001, 114002, 114003
Batch size : 50 kg

SOP list:
06. Batch process according to Manufacturing process sheet (QF/059-29)
(No.-002)
07. Running of steam jacketed Machine (No.- 047 )
08. Running of Colloid mill (No.-027)
SOP list:
SOP for :
01. Analytical Specification of G-Benzosal Ointment (QF/051B-I/003)
02. . Running of UV-Visible Spectrophotometer (CL/017)

SOP list:
SOP for :
1. Sampling and testing of ointment for Process validation (No.CL/028-6)
Title : Process validation of G-Benzosal Ointment

03. Analytical report (QF/045) & Short Laboratory report (QF/026) (mixing stage)
07. Analytical report (QF/045)( After filling)
Verified by: _________________ Date: _____________

Process Validation Gonoshyastho

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Gonoshasthaya Pharmaceuticals Ltd.

Research, Development & Quality Assurance Division

Materials, Equipment, Documents

SOPs for normal operations of the process under test.

Title : Process validation of G- Iron Tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-117)

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

SOPs for normal operations of the process under test.

Title : Process validation of G- Antacid Tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-11)

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

SOPs test specific to the validation study performed.

Title : Process validation of G-Calcium Lactate tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-41)

Verified by: _________________ Date: _____________

SOPs for normal operations of the process under test.

Title : Process validation of G-Paracetamol tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-62)

Verified by: _________________ Date: _____________

SOPs for normal operations of the process under test.

SOPs test specific to the validation study performed.

Title : Process validation of G-Albendazole tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-115)

Verified by: _________________ Date: _____________

SOPs for normal operations of the process under test.

Title : Process validation of G-Antihistamine tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-13)

Verified by: _________________ Date: _____________

SOPs for normal operations of the process under test.

Title : Process validation of G-Metronidazole Tablet

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-55)

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

Title : Process validation of G-Thiopentone Injection

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-109)

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

Title : Process validation of G- Amoxicillin Injection

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-8)

Prepared by: ________________

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

SOPs test specific to the validation study performed.

Title : Process validation of G-Chloramphenical Eye/Ear Drop

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-30)

Verified by: _________________ Date: _____________

Materials, Equipment, Documents

SOPs test specific to the validation study performed.

Title : Process validation of G-Neomycin Eye/Ear ointment

List of attached Data Record Forms

01. Manufacturing batch sheet/ procedure (QF/059-111)

Verified by: _________________ Date: _____________

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Verified by: _____ Date: _

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