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

F
Extension of a stability study for an API
Replies
2
Views
279
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
Replies
6
Views
1,718
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
Replies
4
Views
1,875
jmlbell
O
OTC Pharmaceuticals Labeling Submissions to the FDA
Replies
1
Views
2,151
Ronen E
L
Registration of an Imported Medical Drug in Turkey
Replies
1
Views
3,159
Stijloor
W
Weighing Scale used in Phamaceutical Production - Daily Verification
Replies
8
Views
7,193
Metron
H
IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved
Replies
3
Views
2,329
Ronen E
R
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Replies
2
Views
3,116
rwend07
D
Differences between (c)GMP for Drugs and Medical Devices
Replies
3
Views
7,889
QA-Man
V
Pre-dispensed API material received in predetermined quantities & given to production
Replies
1
Views
2,444
Stijloor
S
Does a Research facility require DEA registration ?
Replies
1
Views
2,712
Stijloor
R
Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem?
Replies
2
Views
3,095
v9991
S
Can I view listed drug products on FDA website similar to listed medical devices?
Replies
4
Views
2,802
v9991
K
Vendor Management for an API Manufacturer?
Replies
4
Views
3,736
v9991
C
Suggestions requested on handling batch record papers exposed to hormonal products
Replies
1
Views
1,854
v9991
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