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

N
Generic Rework/Reprocessing Procedure
Replies
1
Views
2,187
v9991
A
Risks related to Method Validation and Stability Studies
Replies
2
Views
1,312
v9991
F
Extension of a stability study for an API
Replies
2
Views
448
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
Replies
6
Views
1,936
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
Replies
4
Views
2,046
jmlbell
O
OTC Pharmaceuticals Labeling Submissions to the FDA
Replies
1
Views
2,296
Ronen E
L
Registration of an Imported Medical Drug in Turkey
Replies
1
Views
3,351
Stijloor
W
Weighing Scale used in Phamaceutical Production - Daily Verification
Replies
8
Views
7,843
Metron
H
IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved
Replies
3
Views
2,510
Ronen E
R
Contract Manufacturing - OTC (Over the Counter) vs Prescription
Replies
2
Views
3,593
rwend07
D
Differences between (c)GMP for Drugs and Medical Devices
Replies
3
Views
8,633
QA-Man
V
Pre-dispensed API material received in predetermined quantities & given to production
Replies
1
Views
2,623
Stijloor
S
Does a Research facility require DEA registration ?
Replies
1
Views
2,807
Stijloor
R
Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem?
Replies
2
Views
3,308
v9991
S
Can I view listed drug products on FDA website similar to listed medical devices?
Replies
4
Views
2,973
v9991
You must log in or register to post here.
Top Bottom