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

Forum FAQ Threads
Ajit Basrur
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Websites - Medicines Regulatory Authorities (global)
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3,908
Ajit Basrur
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
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5,087
Ajit Basrur
Marc
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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4,545
Marc
Scott Catron
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21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
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6,708
Scott Catron
Scott Catron
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
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21,001
Scott Catron
Forum Discussion Threads
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Generic Rework/Reprocessing Procedure
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20
Noel Townsend
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Extension of a stability study for an API
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2
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64
fall4p
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CFR 21 Definition for Data or Raw Data
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82
ChemistAnalytical
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CTD (Common Technical Document) for a Topical Preparation
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0
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94
aamani
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Should the primary drug containers be molded in ISO Class 7 clean room?
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6
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1,335
SGquality
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Drug packaging / filling operations
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7
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840
paulag
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Risks related to Method Validation and Stability Studies
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1
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531
Ajit Basrur
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European Pharmacopoeia First Identification Requirements
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0
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1,038
hs0wca
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Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines
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4
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1,598
jmlbell
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OTC Pharmaceuticals Labeling Submissions to the FDA
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1
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1,871
Ronen E
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