|
Why control threshold limit is specifically defined as 30% of PDE in ICH Q3D guideline (Elemental impurities)?
|
|
0
|
49
|
August 26, 2021
|
|
Shelf life extension
|
|
0
|
125
|
July 14, 2021
|
|
How to choose molecule for BE study
|
|
1
|
100
|
July 7, 2021
|
|
Pharmacopeial Method Qualification Options
|
|
1
|
181
|
June 1, 2021
|
|
How buyers firstly get to know about the pharma product of a particular company for import
|
|
0
|
85
|
May 30, 2021
|
|
Export dossier for cambodia registration
|
|
0
|
96
|
April 23, 2021
|
|
Biological product
|
|
1
|
97
|
April 20, 2021
|
|
Stability study to establishing of retest date
|
|
0
|
182
|
March 10, 2021
|
|
Clopidogrel tablets
|
|
0
|
113
|
March 4, 2021
|
|
Regulatory Query on Analytical Methods
|
|
0
|
144
|
February 19, 2021
|
|
Regulatory Requirements for conduct clinical trials in USA
|
|
2
|
206
|
February 18, 2021
|
|
Registration and quality issue
|
|
0
|
108
|
February 15, 2021
|
|
Work in Process
|
|
0
|
142
|
January 14, 2021
|
|
Import registration
|
|
3
|
167
|
December 23, 2020
|
|
Regulatory compliance
|
|
2
|
165
|
December 20, 2020
|
|
WHO-GMP REGARDING
|
|
2
|
246
|
December 7, 2020
|
|
Type 1A variation
|
|
1
|
502
|
November 20, 2020
|
|
CMC for IM product by chemical synthesis
|
|
0
|
155
|
November 7, 2020
|
|
Variation of PIL necessary or not?
|
|
0
|
141
|
September 24, 2020
|
|
GMP Facility for multiple product
|
|
2
|
412
|
July 25, 2020
|
|
Separate-manufacturing-facility-for-penicillin-and-non-penicillin-products
|
|
1
|
294
|
June 16, 2020
|
|
Common Technical Document
|
|
0
|
162
|
May 11, 2020
|
|
Impurities Calculation
|
|
0
|
246
|
April 29, 2020
|
|
What are the limitation of GMP in pharma industry
|
|
1
|
363
|
April 28, 2020
|
|
Dissolution study
|
|
1
|
298
|
April 28, 2020
|
|
Stability studies for hand sanitizer
|
|
2
|
361
|
April 28, 2020
|
|
Analytical method validation, DMF, specification, product development report
|
|
0
|
232
|
April 10, 2020
|
|
API or excipient specification by drug product manufacturer
|
|
0
|
207
|
March 26, 2020
|
|
Daily dose of sanitizer?
|
|
1
|
386
|
March 24, 2020
|
|
HAND SANITIZER UNDER COSMETIC OR DRUGS
|
|
1
|
327
|
March 17, 2020
|
