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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10,181
Ajit Basrur
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
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0
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12,332
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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10,737
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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13,471
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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28,098
Scott Catron
Discussions
J
Non_GMP (PIC/S 010) production in a GMP area ?
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630
John_Shepard
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DHF for drug products
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0
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449
Mr. E
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Generic Rework/Reprocessing Procedure
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3
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4,316
v9991
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The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization?
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0
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537
Emily 1113
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Health Authority Inspections
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0
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355
QuinnM
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Validation Methods of Machine learning and Artificial intelligence
2
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10
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962
QuinnM
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Pharmaceuticals and Manufacturing
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0
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488
Kaosfit13
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Parabiotics on the US market
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3
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663
Zero_yield
D
Daily QA Inprocess observation
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2
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687
bengr16
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END CALIBRATION CANNOT BE PERFORMED
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2
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627
Ron Rompen
Anonymous16-2
21 CFR Part 11 - Steps to take if we want to validate an electronic system
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3
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2,177
Alex Kennedy
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Hold Time studies for Primary Reference standards
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0
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611
Idris
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Verify Audit Trail of SaaS system
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5
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1,128
yodon
S
NC and Deviation approach - please help
2
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12
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2,251
Jim Wynne
A
Reduced Testing of Pharmaceutical Raw Materials
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3
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2,518
Satyakumarreddy
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