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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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A
Tabular Gap Analysis of the EU (volume 4) and US (210/211) cGMP Regulations
al in drug dev reg - 2010
Feb 28, 2008
Replies
3
Views
4K
Mar 10, 2008
al in drug dev reg - 2010
A
M
Can a prescription type material be used as a predicate for an OTC material?
melissa66
Mar 6, 2008
Replies
1
Views
2K
Mar 6, 2008
Scott Catron
M
Part 11 Requirements - Medical Devices vs. Pharmaceuticals
mlabardi
Nov 8, 2007
Replies
7
Views
3K
Nov 12, 2007
Ajit Basrur
E
Liability for Packaged Drug products Sold Indirectly in the International Market.
erniel
Oct 23, 2007
Replies
3
Views
2K
Oct 24, 2007
Ajit Basrur
GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US)
Ajit Basrur
Oct 5, 2007
Replies
0
Views
4K
Oct 5, 2007
Ajit Basrur
N
Questions about cGMP in a pharmaceutical company in China
Nancy_Jing
Sep 14, 2007
Replies
6
Views
3K
Sep 24, 2007
Nancy_Jing
N
G
What is the link between FDA and US Pharmacopeia?
Gilberto - 2009
Sep 11, 2007
Replies
3
Views
5K
Sep 12, 2007
Ajit Basrur
J
ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
jfount
Feb 15, 2007
Replies
3
Views
7K
Mar 13, 2007
rrramirez
R
Q
The most current version or draft of the Q10 - Pharmaceutical Quality Systems
qualityboi
Mar 7, 2007
Replies
1
Views
3K
Mar 12, 2007
Marc
Q
Permanent Inspection Readiness for a pharma manufacturing firm
Quality Girl
Dec 19, 2006
Replies
7
Views
6K
Dec 19, 2006
BradM
B
Auditing Pharmaceutical Toll Manufacturers
BEVel
Jul 12, 2006
Replies
1
Views
3K
Jul 16, 2006
Al Rosen
ISO 15378:2006, Primary packaging materials for medicinal products
Sidney Vianna
Mar 28, 2006
Replies
0
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10K
Mar 28, 2006
Sidney Vianna
T
Comparison of EU and US GMPs - Differences applying CFR211 or the EU GMPs
tomlove
Feb 27, 2006
Replies
1
Views
5K
Mar 6, 2006
Al Rosen
B
SUPAC (Scale Up and Post Approval Changes) guidelines for pharmaceuticals
BEVel
Feb 21, 2006
Replies
2
Views
18K
Feb 21, 2006
BEVel
B
D
Tracebility requirements in Pharma vs Medical Devices - Nonconformance issue
Deep Krothapalli
Feb 16, 2005
Replies
3
Views
3K
Feb 17, 2005
Al Rosen
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