Process Validation Gonoshyastho
Process Validation Gonoshyastho
Process Validation Gonoshyastho
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
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)
5 03. Determination of Friability (No.-CL/26)
04. Analytical Specification of finished product (QF/051B- )
05. 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 Friability test Machine (QF/053A-6)
04. Calibration of Moisture Analyser (QF/053A-1)
Validation Protocol : Process validation Page of
Prepared by : ________________
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/009)
03. Determination of disintegration (No.-CL/25)
6 04. Determination of Friability (No.-CL/26)
05. Analytical Specification of finished product (QF/051B-B/009)
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/024)
03. Determination of disintegration (No.-CL/25)
7 04. Determination of Friability (No.-CL/26)
05. Analytical Specification of finished product (QF/051B-B/024)
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)
1. Calibration of Friability test Machine (QF/053A-6)
Validation Protocol : Process validation Page of
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/051-A/030)
8 03. Determination of Friability (No.-CL/26)
04. Analytical Specification of finished product (QF/051-B/030)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Thiopentone Injection (QF/051B-G/005)
2. Running of PH meter (No.-CL/013)
3. Running of UV-Visible Spectrophotometer (CL/017)
04. Sterility test (No.-MW/25)
SOPs test specific to the validation study performed.
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 UV-Visible Spectrophotometer (QF/053A-2)
04. Calibration of Getinge Programmable Autoclave (No.- )
Validation Protocol : Process validation Page of
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G- Amoxicillin Injection (QF/051B-G/003)
4. Running of PH meter (No.-CL/013)
5. Running of UV-Visible Spectrophotometer (CL/017)
04. Sterility test (No.-MW/25)
SOPs test specific to the validation study performed.
SOP list:
SOP for :
1. Sampling and testing of dry vial Injection for Process validation
(No.CL/028-6)
02. Calibration of PH meter (QF/053A)
03. Calibration of UV-Visible Spectrophotometer (QF/053A-2)
04. Calibration of Getinge Programmable Autoclave (No.- )
Validation Protocol : Process validation Page of
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Chloramphenical (QF/051B-L/001)
2. Sterility test (No.-MW/25)
03. Running of Oven (No.-CL/006)
Prepared by : ______________
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Neomycxin ointment (QF/ )
3. Sterility test (No.-MW/25)
03. Running of Oven (No.-CL/006)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Diazepam Injection (QF/051A-E/011)
02. Running of PH meter (No.-CL/013)
03. Sterility test (No.-MW/25)
Prepared by : ________________
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Paracetamol Syrup (QF/051-C/004)
02. Running of UV-Visible Spectrophotometer (CL/017)
03. Running of PH meter (No.-CL/013)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Antacid suspension (QF/051-C/ )
02. Running of PH meter (No.-CL/013)
Prepared by : _______________
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 G-Amoxicillin Dry Syrup (QF/051B-D/003)
03. Running of PH meter (No.-CL/013)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Moisture determination ( No.-CL/27)
18 02. Analytical Specification of G-Amoxicillin 500 mg capsule(QF/051B-H/008)
Prepared by : ________________
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 G-Tetracycline capsule (QF/051B-H/003)
03. Running of UV-Visible Spectrophotometer (CL/017)
SOPs for in-process and quality control tests performed during process .
SOP list:
SOP for :
01. Analytical Specification of G-Benzosal Ointment (QF/051B-I/003)
02. . Running of UV-Visible Spectrophotometer (CL/017)