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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)
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FAQs
Sticky
Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
Replies
0
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6,651
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
Views
8,474
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
Replies
0
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7,173
Oct 18, 2009
Marc
Sticky
21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling
Scott Catron
Apr 22, 2008
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9,830
Apr 22, 2008
Scott Catron
Locked
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
Scott Catron
Apr 22, 2008
Replies
0
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24,144
Apr 22, 2008
Scott Catron
Discussions
S
ISO 9001:2015 vs 21 CFR Part 211 matrix
sdedonder
Jan 3, 2021
Replies
0
Views
183
Jan 3, 2021
sdedonder
K
Comparison wanted: ISO 15378:2018 vs. PS9000:2016
katinkaszekeres
Dec 1, 2020
Replies
0
Views
221
Dec 1, 2020
katinkaszekeres
Z
Labeler Code - Private labelling for OTC (Over the Counter)
zeb.d
Nov 13, 2020
Replies
0
Views
193
Nov 13, 2020
zeb.d
New Job with Wholesale Distributor
XRAY_3121
Oct 5, 2020
Replies
0
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326
Oct 5, 2020
XRAY_3121
B
Retention Samples when Customer Leaves
BlackHeart
Sep 18, 2020
Replies
1
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368
Sep 19, 2020
v9991
Q
Project Tracker - Something that shows the status of each project
qualitytam
May 5, 2020
Replies
5
Views
883
Aug 5, 2020
qualprod
21 CFR Part 11 - Steps to take if we want to validate an electronic system
Anonymous16-2
Aug 4, 2020
Replies
2
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540
Aug 4, 2020
yodon
Labeling Question (Dietary Supplements/Food)
Anonymous16-2
Jul 31, 2020
Replies
1
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418
Aug 3, 2020
Anonymous16-2
Q
Legal Manufacturer OTC Drug
Quality Sailor
Jul 13, 2020
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0
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401
Jul 13, 2020
Quality Sailor
E
21 CFR 211.103 Calculation of Yield
emorin
Jun 10, 2020
Replies
5
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844
Jun 12, 2020
Marc
Q
Serialization and Reconciliation of Forms
qualitytam
May 5, 2020
Replies
7
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762
May 14, 2020
Jean_B
E
Non-GMP examples in Pharmaceutical industry
elsmargirl2020
May 8, 2020
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2
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655
May 8, 2020
elsmargirl2020
L
Wearables 21 CFR Part 11 compliance
Lily11
Mar 3, 2020
Replies
1
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814
Mar 3, 2020
yodon
K
Validation of new machine (second machine of the same type)
Kid006
Jan 22, 2020
Replies
2
Views
805
Jan 22, 2020
Kid006
M
Can a PLD Registered in only one state sell prescription drugs to one in another state
me too
Dec 24, 2019
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0
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590
Dec 24, 2019
me too
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