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

A
Reduced Testing of Pharmaceutical Raw Materials
Replies
2
Views
1,213
AAA211
H
Communication plan according to ISO9001 - Pharmaceutical field
Replies
3
Views
918
John Broomfield
M
How to validate a Dye Test method used to evaluate Package Integrity
Replies
8
Views
3,636
Ronen E
J
GLP recognition via SCC (Standards Council of Canada)
Replies
1
Views
2,804
Marc
V
Site Master File for multiple business units within same premises/facility
Replies
1
Views
2,925
Marc
K
Release testing for Combination Drug-Medical Device
Replies
0
Views
345
Kjenks1
P
HVAC System vs Air Handling Unit (AHU) - Differences
Replies
1
Views
911
Marc
P
Fan filter unit (un-ducted to air supply) vs fan filter unit (ducted to air supply)
Replies
1
Views
389
somashekar
M
Pharmaceuticals Warehouse temperature control (room temperature)
Replies
3
Views
573
melancholy
P
ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed?
Replies
2
Views
1,699
pcamejo
D
FDA filing guidance to add sterilization step for approved drug
Replies
8
Views
1,183
drhkp
V
Additional Controls for processing the raw data on different computers (processing system)
Replies
5
Views
605
yodon
D
Key Performance Indicators in a Pharmaceutical Company
2
Replies
13
Views
31,634
v9991
P
Drug packaging / filling operations
Replies
8
Views
1,589
v9991
H
European Pharmacopoeia First Identification Requirements
Replies
1
Views
3,228
v9991
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