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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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Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
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4,490
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
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5,857
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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0
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5,059
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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7,311
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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21,680
Apr 22, 2008
Scott Catron
Discussions
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Unit Dose Packaging
Elleder
Sep 11, 2019
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40
Sep 11, 2019
Elleder
C
Locked
Raw material Mixing / Preparation for clean room class C injection molding
chemist_tma
Sep 10, 2019
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1
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53
Sep 10, 2019
Ronen E
M
Identical Sales Package in Different Countries
Mallappa
Aug 22, 2019
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0
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92
Aug 22, 2019
Mallappa
B
Machine process sheet requirements for pill bottling operation
BHayes
Aug 1, 2019
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1
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148
Aug 1, 2019
Ronen E
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21 CFR and Annex 11 mapping document
ZEE9995
Jul 30, 2019
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1
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126
Jul 30, 2019
yodon
E
How much a bioequivalence study will cost in the UK
Ellie Bowler
Jul 15, 2019
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158
Jul 15, 2019
Ellie Bowler
S
Looking for templates of Master Production Record and Master Batch record
SGquality
Aug 13, 2016
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3
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5,243
Jul 9, 2019
sherniece
C
Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals
ChemistAnalytical
Jan 15, 2019
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3
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387
Jul 9, 2019
hd designer
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Electronic Logbook Software - 21 CFR part 211 environment (CFR 211.182)
DiceNa
Sep 3, 2013
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6
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6,358
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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256
Jun 28, 2019
Ronen E
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Reduced Testing of Pharmaceutical Raw Materials
AAA211
Jun 11, 2019
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2
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344
Jun 18, 2019
AAA211
H
Communication plan according to ISO9001 - Pharmaceutical field
hd designer
May 25, 2019
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3
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303
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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3,253
May 21, 2019
Ronen E
J
GLP recognition via SCC (Standards Council of Canada)
JJ_FDA
Jun 26, 2015
Replies
1
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2,631
May 15, 2019
Marc
V
Site Master File for multiple business units within same premises/facility
v9991
Jul 5, 2016
Replies
1
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2,738
May 15, 2019
Marc
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National and International Business System Standards
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