|
OOS and Cleaning Validation
|
|
1
|
68
|
June 15, 2021
|
|
Gmp facility cleaning protocol with reference
|
|
0
|
59
|
June 10, 2021
|
|
Existing Cephalosporin facility for manufacturing other types of normal product (e.g. Tablets, liquids)
|
|
2
|
85
|
June 6, 2021
|
|
WHO TRS 1033 published in March 2021
|
|
0
|
347
|
April 1, 2021
|
|
Different facility requirements for Penems, Cefa & Penicillin
|
|
2
|
196
|
October 4, 2020
|
|
Is ursodeoxycholic acid a steroid?
|
|
0
|
110
|
September 17, 2020
|
|
New WHO TRS 1025 (2020)
|
|
0
|
223
|
August 9, 2020
|
|
How to conduct audit in HEPA filter
|
|
3
|
679
|
June 30, 2020
|
|
Drying of stainless steel trays
|
|
0
|
133
|
June 30, 2020
|
|
Weight variation of tablet & capsule
|
|
3
|
487
|
May 29, 2020
|
|
GMP certification
|
|
1
|
901
|
May 29, 2020
|
|
Please provide me sample formates for DMF I, II, III, IV and V
|
|
0
|
163
|
May 9, 2020
|
|
Pressure and Passivation Testing in the Qualifications
|
|
0
|
179
|
April 2, 2020
|
|
Could a R&D (analytical or formulation) personnel avoid wearing cap? what should be then the dress code for R&D? Is R&D a non GMP complied area?
|
|
3
|
303
|
March 30, 2020
|
|
Expiry date for the raw materials
|
|
6
|
1083
|
March 27, 2020
|
|
GMP principals for hazardous drug manufacturing
|
|
1
|
553
|
March 2, 2020
|
|
Separate API forum required
|
|
0
|
185
|
February 15, 2020
|
|
Segregation of roles
|
|
0
|
160
|
February 12, 2020
|
|
Equipment change in facility
|
|
3
|
385
|
January 29, 2020
|
|
Use of Round off rule
|
|
0
|
224
|
January 28, 2020
|
|
Shipper (Final Pack) Weighing in paharmaceutical packaging
|
|
0
|
246
|
January 12, 2020
|
|
Effectiveness for Change control
|
|
0
|
309
|
November 19, 2019
|
|
Production and Guidelines
|
|
0
|
350
|
November 18, 2019
|
|
How many HEPA filters will be placed in a clean room? and where it should be placed?
|
|
3
|
1100
|
June 13, 2019
|
|
Process Analytical Technology (PAT)
|
|
1
|
284
|
May 6, 2019
|
|
Heating , ventilation and Air conditiong system
|
|
3
|
446
|
March 22, 2019
|
|
What is the responsibility of technical supervisor in production unit
|
|
3
|
384
|
March 21, 2019
|
|
ASQ CertifiedcGMP Professional
|
|
0
|
241
|
January 7, 2019
|
|
What action to be taken if an OOT result is confirmed
|
|
7
|
1600
|
September 10, 2018
|
|
Garment according to the clean room
|
|
2
|
464
|
September 6, 2018
|
