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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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0
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4,716
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
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6,120
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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5,300
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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0
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7,547
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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21,946
Apr 22, 2008
Scott Catron
Discussions
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Sterility and Bioburden Testing - LAL passed under 0.5EU/mL
Cleslie22
Yesterday at 5:27 PM
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3
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48
Today at 10:35 AM
planB
E
Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list)
emorin
Oct 28, 2019
Replies
2
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156
Oct 29, 2019
indubioush
D
What is the best software used for the pharma compliance management?
duckdonald
Sep 26, 2019
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0
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197
Sep 26, 2019
duckdonald
E
Unit Dose Packaging
Elleder
Sep 11, 2019
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146
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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150
Sep 10, 2019
Ronen E
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Identical Sales Package in Different Countries
Mallappa
Aug 22, 2019
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186
Aug 22, 2019
Mallappa
B
Machine process sheet requirements for pill bottling operation
BHayes
Aug 1, 2019
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238
Aug 1, 2019
Ronen E
Z
21 CFR and Annex 11 mapping document
ZEE9995
Jul 30, 2019
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1
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218
Jul 30, 2019
yodon
E
How much a bioequivalence study will cost in the UK
Ellie Bowler
Jul 15, 2019
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0
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248
Jul 15, 2019
Ellie Bowler
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Looking for templates of Master Production Record and Master Batch record
SGquality
Aug 13, 2016
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3
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5,461
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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491
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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6,522
Jul 2, 2019
Vivek Sazawal
K
How Many Samples to send for Chemistry Testing
Kjenks1
Jun 26, 2019
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3
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358
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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448
Jun 18, 2019
AAA211
H
Communication plan according to ISO9001 - Pharmaceutical field
hd designer
May 25, 2019
Replies
3
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382
May 27, 2019
John Broomfield
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National and International Business System Standards
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