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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6,651
Ajit Basrur
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
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0
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8,474
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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7,173
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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9,830
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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24,144
Scott Catron
Discussions
S
ISO 9001:2015 vs 21 CFR Part 211 matrix
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0
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183
sdedonder
K
Comparison wanted: ISO 15378:2018 vs. PS9000:2016
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0
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221
katinkaszekeres
Z
Labeler Code - Private labelling for OTC (Over the Counter)
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0
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193
zeb.d
XRAY_3121
New Job with Wholesale Distributor
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0
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326
XRAY_3121
B
Retention Samples when Customer Leaves
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1
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368
v9991
Q
Project Tracker - Something that shows the status of each project
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5
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883
qualprod
Anonymous16-2
21 CFR Part 11 - Steps to take if we want to validate an electronic system
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2
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540
yodon
Anonymous16-2
Labeling Question (Dietary Supplements/Food)
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1
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418
Anonymous16-2
Q
Legal Manufacturer OTC Drug
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0
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401
Quality Sailor
E
21 CFR 211.103 Calculation of Yield
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5
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844
Marc
Q
Serialization and Reconciliation of Forms
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7
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762
Jean_B
E
Non-GMP examples in Pharmaceutical industry
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2
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655
elsmargirl2020
L
Wearables 21 CFR Part 11 compliance
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1
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814
yodon
K
Validation of new machine (second machine of the same type)
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2
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805
Kid006
M
Can a PLD Registered in only one state sell prescription drugs to one in another state
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0
Views
590
me too
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