|
Biological product
|
|
1
|
509
|
April 20, 2021
|
|
Stability study to establishing of retest date
|
|
0
|
517
|
March 10, 2021
|
|
Clopidogrel tablets
|
|
0
|
426
|
March 4, 2021
|
|
Regulatory Query on Analytical Methods
|
|
0
|
689
|
February 19, 2021
|
|
Regulatory Requirements for conduct clinical trials in USA
|
|
2
|
1450
|
February 18, 2021
|
|
Registration and quality issue
|
|
0
|
407
|
February 15, 2021
|
|
Work in Process
|
|
0
|
471
|
January 14, 2021
|
|
Import registration
|
|
3
|
720
|
December 23, 2020
|
|
Regulatory compliance
|
|
2
|
640
|
December 20, 2020
|
|
WHO-GMP REGARDING
|
|
2
|
635
|
December 7, 2020
|
|
Type 1A variation
|
|
1
|
866
|
November 20, 2020
|
|
CMC for IM product by chemical synthesis
|
|
0
|
458
|
November 7, 2020
|
|
Variation of PIL necessary or not?
|
|
0
|
442
|
September 24, 2020
|
|
GMP Facility for multiple product
|
|
2
|
678
|
July 25, 2020
|
|
Separate-manufacturing-facility-for-penicillin-and-non-penicillin-products
|
|
1
|
742
|
June 16, 2020
|
|
Common Technical Document
|
|
0
|
462
|
May 11, 2020
|
|
Impurities Calculation
|
|
0
|
558
|
April 29, 2020
|
|
What are the limitation of GMP in pharma industry
|
|
1
|
661
|
April 28, 2020
|
|
Dissolution study
|
|
1
|
717
|
April 28, 2020
|
|
Stability studies for hand sanitizer
|
|
2
|
842
|
April 28, 2020
|
|
Analytical method validation, DMF, specification, product development report
|
|
0
|
617
|
April 10, 2020
|
|
API or excipient specification by drug product manufacturer
|
|
0
|
492
|
March 26, 2020
|
|
Daily dose of sanitizer?
|
|
1
|
625
|
March 24, 2020
|
|
HAND SANITIZER UNDER COSMETIC OR DRUGS
|
|
1
|
567
|
March 17, 2020
|
|
Example of LOA for Type III DMF Holder
|
|
0
|
461
|
February 26, 2020
|
|
Good Laboratory Practices (GLP)
|
|
2
|
614
|
February 17, 2020
|
|
ASSAY limits for products under Stability
|
|
5
|
1106
|
February 14, 2020
|
|
Open part of DMF(USDMF)
|
|
0
|
594
|
February 3, 2020
|
|
Standing Regulatory Members of ICH
|
|
1
|
1250
|
January 28, 2020
|
|
List of permitted excipients with respective quantities
|
|
1
|
666
|
January 3, 2020
|