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

FAQs
Ajit Basrur
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Websites - Medicines Regulatory Authorities (global)
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0
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8,089
Ajit Basrur
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
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0
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10,140
Ajit Basrur
Marc
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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0
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8,595
Marc
Scott Catron
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21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
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0
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11,331
Scott Catron
Scott Catron
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
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0
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25,827
Scott Catron
Discussions
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NC and Deviation approach - please help
2
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12
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473
Jim Wynne
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Reduced Testing of Pharmaceutical Raw Materials
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3
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1,674
Satyakumarreddy
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Equivalent role of QP (Qualified Person) in FDA Regulations
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9
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10,924
pbojsen
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Pharmaceutical Shelf Life Testing
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0
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240
Sarahb333
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Verify Audit Trail of SaaS system
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3
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316
yodon
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Static Mixer on Solution production Mixer
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0
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253
ifserav
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211, subpart B, section 211.22 as it applies to pharma printing
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3
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362
indubioush
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Water requirement for Non-sterile topical OTCs
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0
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788
Lacarrye
B
New Facility register with FDA
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4
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1,000
William55401
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Sterilized components shelf life
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1
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603
planB
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ISO 9001:2015 vs 21 CFR Part 211 matrix
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0
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1,140
sdedonder
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Comparison wanted: ISO 15378:2018 vs. PS9000:2016
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0
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860
katinkaszekeres
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Labeler Code - Private labelling for OTC (Over the Counter)
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0
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740
zeb.d
XRAY_3121
New Job with Wholesale Distributor
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0
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831
XRAY_3121
B
Retention Samples when Customer Leaves
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1
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903
v9991
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