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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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7,516
Ajit Basrur
Ajit Basrur
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ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
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0
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9,515
Ajit Basrur
Marc
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ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Replies
0
Views
8,032
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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10,743
Scott Catron
Scott Catron
  • Locked
  • Sticky
21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
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0
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25,216
Scott Catron
Discussions
L
Water requirement for Non-sterile topical OTCs
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0
Views
550
Lacarrye
B
New Facility register with FDA
Replies
4
Views
753
William55401
T
Sterilized components shelf life
Replies
1
Views
421
planB
S
ISO 9001:2015 vs 21 CFR Part 211 matrix
Replies
0
Views
788
sdedonder
K
Comparison wanted: ISO 15378:2018 vs. PS9000:2016
Replies
0
Views
626
katinkaszekeres
Z
Labeler Code - Private labelling for OTC (Over the Counter)
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0
Views
529
zeb.d
XRAY_3121
New Job with Wholesale Distributor
Replies
0
Views
627
XRAY_3121
B
Retention Samples when Customer Leaves
Replies
1
Views
702
v9991
Q
Project Tracker - Something that shows the status of each project
Replies
5
Views
1,345
qualprod
Anonymous16-2
21 CFR Part 11 - Steps to take if we want to validate an electronic system
Replies
2
Views
1,023
yodon
Anonymous16-2
Labeling Question (Dietary Supplements/Food)
Replies
1
Views
732
Anonymous16-2
Q
Legal Manufacturer OTC Drug
Replies
0
Views
713
Quality Sailor
E
21 CFR 211.103 Calculation of Yield
Replies
5
Views
1,618
Marc
Q
Serialization and Reconciliation of Forms
Replies
7
Views
1,273
Jean_B
E
Non-GMP examples in Pharmaceutical industry
Replies
2
Views
1,283
elsmargirl2020
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