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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)
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Drug packaging / filling operations
paulag
Mar 13, 2018
Replies
8
Views
1,648
Dec 31, 2018
v9991
H
European Pharmacopoeia First Identification Requirements
hs0wca
Jan 9, 2018
Replies
1
Views
3,584
Dec 31, 2018
v9991
A
CTD (Common Technical Document) for a Topical Preparation
aamani
Sep 22, 2018
Replies
2
Views
1,200
Dec 31, 2018
Ajit Basrur
C
Informational
CFR 21 Definition for Data or Raw Data
ChemistAnalytical
Sep 24, 2018
Replies
5
Views
1,572
Dec 30, 2018
Marc
N
Generic Rework/Reprocessing Procedure
Noel Townsend
Oct 16, 2018
Replies
1
Views
2,845
Dec 30, 2018
v9991
A
Risks related to Method Validation and Stability Studies
abdou2013
Feb 26, 2018
Replies
2
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1,434
Dec 30, 2018
v9991
F
Extension of a stability study for an API
fall4p
Oct 4, 2018
Replies
2
Views
512
Oct 5, 2018
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
SGquality
Jun 14, 2018
Replies
6
Views
2,010
Jun 18, 2018
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
jmlbell
Aug 21, 2017
Replies
4
Views
2,100
Aug 22, 2017
jmlbell
O
OTC Pharmaceuticals Labeling Submissions to the FDA
oligomer3
Jun 3, 2017
Replies
1
Views
2,359
Jun 4, 2017
Ronen E
L
Registration of an Imported Medical Drug in Turkey
Lilac18
Nov 22, 2016
Replies
1
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3,419
Jan 23, 2017
Stijloor
W
Weighing Scale used in Phamaceutical Production - Daily Verification
WalkingSeed
Feb 14, 2013
Replies
8
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8,080
Dec 4, 2016
Metron
H
IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved
HeatherC-S
Nov 3, 2016
Replies
3
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2,584
Nov 8, 2016
Ronen E
R
Contract Manufacturing - OTC (Over the Counter) vs Prescription
rwend07
Aug 4, 2016
Replies
2
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3,777
Sep 21, 2016
rwend07
D
Differences between (c)GMP for Drugs and Medical Devices
Dudes
May 21, 2012
Replies
3
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8,916
Sep 20, 2016
QA-Man
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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