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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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Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
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Jan 2, 2012
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
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5,127
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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4,577
Oct 18, 2009
Marc
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21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
Scott Catron
Apr 22, 2008
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Apr 22, 2008
Scott Catron
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
Scott Catron
Apr 22, 2008
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Apr 22, 2008
Scott Catron
Forum Discussion Threads
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CFR 21 Definition for Data or Raw Data
ChemistAnalytical
Sep 24, 2018
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3
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156
Nov 2, 2018
supadrai
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Generic Rework/Reprocessing Procedure
Noel Townsend
Oct 16, 2018
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83
Oct 16, 2018
Noel Townsend
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Extension of a stability study for an API
fall4p
Oct 4, 2018
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111
Oct 5, 2018
fall4p
A
CTD (Common Technical Document) for a Topical Preparation
aamani
Sep 22, 2018
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123
Sep 22, 2018
aamani
S
Should the primary drug containers be molded in ISO Class 7 clean room?
SGquality
Jun 14, 2018
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1,391
Jun 18, 2018
SGquality
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Drug packaging / filling operations
paulag
Mar 13, 2018
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907
Mar 15, 2018
paulag
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Risks related to Method Validation and Stability Studies
abdou2013
Feb 26, 2018
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585
Feb 26, 2018
Ajit Basrur
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European Pharmacopoeia First Identification Requirements
hs0wca
Jan 9, 2018
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1,072
Jan 9, 2018
hs0wca
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Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
jmlbell
Aug 21, 2017
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1,642
Aug 22, 2017
jmlbell
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OTC Pharmaceuticals Labeling Submissions to the FDA
oligomer3
Jun 3, 2017
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1,920
Jun 4, 2017
Ronen E
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Registration of an Imported Medical Drug in Turkey
Lilac18
Nov 22, 2016
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Jan 23, 2017
Stijloor
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Weighing Scale used in Phamaceutical Production - Daily Verification
WalkingSeed
Feb 14, 2013
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6,527
Dec 4, 2016
Metron
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IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved
HeatherC-S
Nov 3, 2016
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2,055
Nov 8, 2016
Ronen E
S
Looking for templates of Master Production Record and Master Batch record
SGquality
Aug 13, 2016
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4,249
Oct 8, 2016
v9991
R
Contract Manufacturing - OTC (Over the Counter) vs Prescription
rwend07
Aug 4, 2016
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Sep 21, 2016
rwend07
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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