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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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Pre-dispensed API material received in predetermined quantities & given to production
v9991
Aug 3, 2016
Replies
1
Views
2,681
Aug 16, 2016
Stijloor
S
Does a Research facility require DEA registration ?
SGquality
Jun 12, 2015
Replies
1
Views
2,850
May 23, 2016
Stijloor
R
Review of "Key Data" for contract labs, but SOP doesn't define "key data". Problem?
Robert in SF
May 7, 2015
Replies
2
Views
3,391
May 18, 2016
v9991
S
Can I view listed drug products on FDA website similar to listed medical devices?
SGquality
Jan 19, 2015
Replies
4
Views
3,036
May 16, 2016
v9991
K
Vendor Management for an API Manufacturer?
KDail
Jun 16, 2015
Replies
4
Views
4,155
May 16, 2016
v9991
C
Suggestions requested on handling batch record papers exposed to hormonal products
compliance24
May 12, 2016
Replies
1
Views
2,018
May 14, 2016
v9991
E
Pallets need to be changed when raw materials are transferring from WH to MFG area?
Eric Chang
Apr 11, 2015
Replies
6
Views
3,499
Apr 14, 2015
somashekar
S
Could Phase III Clinical Trials be taken without Phase I and II ?
SGquality
Jan 22, 2015
Replies
2
Views
3,096
Jan 27, 2015
Ajit Basrur
P
Is it required to audit per 21 CFR Part 211 ?
pkauffman
Jan 26, 2015
Replies
2
Views
3,236
Jan 26, 2015
Ronen E
V
Batch Chromatography API - Blending of Batches
validationeng
Oct 22, 2014
Replies
4
Views
2,393
Oct 24, 2014
validationeng
New Guideline from ICH proposed on Lifecycle Management - Q12
Ajit Basrur
Oct 21, 2014
Replies
2
Views
2,236
Oct 21, 2014
Ajit Basrur
V
Analysis of 'Value Added' System & Process Steps - Inspection
v9991
Oct 12, 2014
Replies
2
Views
1,834
Oct 13, 2014
lokeky1
FDA Guidance Document - Expedited Programs for Serious Conditions ? Drugs & Biologics
Ajit Basrur
May 29, 2014
Replies
0
Views
1,844
May 29, 2014
Ajit Basrur
F
Medicinal Product Registration Requirements in Brazil
fernandoelcasir
Aug 26, 2010
Replies
2
Views
3,071
May 15, 2014
Green Med
N
What brand of scales do you use in pharma?
New to QA
Jul 26, 2013
Replies
6
Views
2,387
Apr 30, 2014
Automatic
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National and International Business System Standards
Food and Drug (Pharmaceuticals) related Regulations
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