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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
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Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
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0
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4,320
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
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5,645
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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4,883
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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7,130
Apr 22, 2008
Scott Catron
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21 CFR parts 210 and 211 - CURRENT GMP FOR FINISHED PHARMACEUTICALS
Scott Catron
Apr 22, 2008
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21,488
Apr 22, 2008
Scott Catron
Discussions
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How much a bioequivalence study will cost in the UK
Ellie Bowler
Monday at 8:42 AM
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43
Monday at 8:42 AM
Ellie Bowler
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Looking for templates of Master Production Record and Master Batch record
SGquality
Aug 13, 2016
Replies
3
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5,051
Jul 9, 2019
sherniece
C
Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals
ChemistAnalytical
Jan 15, 2019
Replies
3
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290
Jul 9, 2019
hd designer
D
Electronic Logbook Software - 21 CFR part 211 environment (CFR 211.182)
DiceNa
Sep 3, 2013
Replies
6
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6,172
Jul 2, 2019
Vivek Sazawal
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How Many Samples to send for Chemistry Testing
Kjenks1
Jun 26, 2019
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3
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146
Jun 28, 2019
Ronen E
A
Reduced Testing of Pharmaceutical Raw Materials
AAA211
Jun 11, 2019
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2
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216
Jun 18, 2019
AAA211
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Communication plan according to ISO9001 - Pharmaceutical field
hd designer
May 25, 2019
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3
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188
May 27, 2019
John Broomfield
M
How to validate a Dye Test method used to evaluate Package Integrity
mayrita01
Mar 1, 2012
Replies
8
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3,158
May 21, 2019
Ronen E
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GLP recognition via SCC (Standards Council of Canada)
JJ_FDA
Jun 26, 2015
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1
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2,596
May 15, 2019
Marc
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Site Master File for multiple business units within same premises/facility
v9991
Jul 5, 2016
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2,714
May 15, 2019
Marc
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Release testing for Combination Drug-Medical Device
Kjenks1
May 13, 2019
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145
May 13, 2019
Kjenks1
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HVAC System vs Air Handling Unit (AHU) - Differences
Peter Ruzangi
May 8, 2019
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1
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141
May 8, 2019
Marc
P
Fan filter unit (un-ducted to air supply) vs fan filter unit (ducted to air supply)
Peter Ruzangi
May 3, 2019
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1
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156
May 4, 2019
somashekar
M
Pharmaceuticals Warehouse temperature control (room temperature)
melancholy
Apr 23, 2019
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3
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165
Apr 26, 2019
melancholy
P
ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed?
pcamejo
Feb 4, 2019
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2
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386
Feb 5, 2019
pcamejo
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National and International Business System Standards
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