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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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FAQs
Sticky
Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
Replies
0
Views
4,061
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
Views
5,349
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
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4,674
Oct 18, 2009
Marc
Sticky
21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
Scott Catron
Apr 22, 2008
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0
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6,880
Apr 22, 2008
Scott Catron
Locked
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
Scott Catron
Apr 22, 2008
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21,246
Apr 22, 2008
Scott Catron
Discussions
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ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed?
pcamejo
Feb 4, 2019
Replies
2
Views
168
Feb 5, 2019
pcamejo
C
Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals
ChemistAnalytical
Jan 15, 2019
Replies
0
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109
Jan 15, 2019
ChemistAnalytical
D
FDA filing guidance to add sterilization step for approved drug
drhkp
Dec 23, 2018
Replies
8
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359
Jan 10, 2019
drhkp
V
Additional Controls for processing the raw data on different computers (processing system)
v9991
Dec 30, 2018
Replies
5
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161
Jan 3, 2019
yodon
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Key Performance Indicators in a Pharmaceutical Company
dehnad2001
Aug 4, 2006
2
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13
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29,807
Jan 1, 2019
v9991
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Drug packaging / filling operations
paulag
Mar 13, 2018
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8
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1,111
Dec 31, 2018
v9991
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European Pharmacopoeia First Identification Requirements
hs0wca
Jan 9, 2018
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1
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1,310
Dec 31, 2018
v9991
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CTD (Common Technical Document) for a Topical Preparation
aamani
Sep 22, 2018
Replies
2
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285
Dec 31, 2018
Ajit Basrur
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Informational
CFR 21 Definition for Data or Raw Data
ChemistAnalytical
Sep 24, 2018
Replies
5
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408
Dec 30, 2018
Marc
N
Generic Rework/Reprocessing Procedure
Noel Townsend
Oct 16, 2018
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1
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368
Dec 30, 2018
v9991
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Risks related to Method Validation and Stability Studies
abdou2013
Feb 26, 2018
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767
Dec 30, 2018
v9991
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Extension of a stability study for an API
fall4p
Oct 4, 2018
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2
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201
Oct 5, 2018
fall4p
S
Should the primary drug containers be molded in ISO Class 7 clean room?
SGquality
Jun 14, 2018
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6
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1,551
Jun 18, 2018
SGquality
J
Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
jmlbell
Aug 21, 2017
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4
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1,781
Aug 22, 2017
jmlbell
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OTC Pharmaceuticals Labeling Submissions to the FDA
oligomer3
Jun 3, 2017
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2,039
Jun 4, 2017
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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