Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

D
FDA filing guidance to add sterilization step for approved drug
Replies
8
Views
900
drhkp
V
Additional Controls for processing the raw data on different computers (processing system)
Replies
5
Views
442
yodon
D
Key Performance Indicators in a Pharmaceutical Company
2
Replies
13
Views
31,090
v9991
P
Drug packaging / filling operations
Replies
8
Views
1,424
v9991
H
European Pharmacopoeia First Identification Requirements
Replies
1
Views
2,375
v9991
A
CTD (Common Technical Document) for a Topical Preparation
Replies
2
Views
583
Ajit Basrur
C
Informational CFR 21 Definition for Data or Raw Data
Replies
5
Views
1,002
Marc
N
Generic Rework/Reprocessing Procedure
Replies
1
Views
1,471
v9991
A
Risks related to Method Validation and Stability Studies
Replies
2
Views
1,120
v9991
F
Extension of a stability study for an API
Replies
2
Views
339
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
Replies
6
Views
1,818
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
Replies
4
Views
1,951
jmlbell
O
OTC Pharmaceuticals Labeling Submissions to the FDA
Replies
1
Views
2,218
Ronen E
L
Registration of an Imported Medical Drug in Turkey
Replies
1
Views
3,255
Stijloor
W
Weighing Scale used in Phamaceutical Production - Daily Verification
Replies
8
Views
7,577
Metron
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