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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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5,329
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
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0
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6,946
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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5,897
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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8,307
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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22,686
Apr 22, 2008
Scott Catron
Discussions
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Wearables 21 CFR Part 11 compliance
Lily11
Mar 3, 2020
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192
Mar 3, 2020
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Validation of new machine (second machine of the same type)
Kid006
Jan 22, 2020
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323
Jan 22, 2020
Kid006
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Can a PLD Registered in only one state sell prescription drugs to one in another state
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Dec 24, 2019
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256
Dec 24, 2019
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Security and access in cGMP facilities
ChemistAnalytical
Dec 17, 2019
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1
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208
Dec 17, 2019
Ronen E
E
Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list)
emorin
Oct 28, 2019
Replies
3
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485
Dec 17, 2019
QHawk
C
Sterility and Bioburden Testing - LAL passed under 0.5EU/mL
Cleslie22
Nov 12, 2019
Replies
3
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410
Nov 13, 2019
planB
D
What is the best software used for the pharma compliance management?
duckdonald
Sep 26, 2019
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393
Sep 26, 2019
duckdonald
E
Unit Dose Packaging
Elleder
Sep 11, 2019
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332
Sep 11, 2019
Elleder
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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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352
Sep 10, 2019
Ronen E
M
Identical Sales Package in Different Countries
Mallappa
Aug 22, 2019
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371
Aug 22, 2019
Mallappa
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Machine process sheet requirements for pill bottling operation
BHayes
Aug 1, 2019
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443
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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413
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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429
Jul 15, 2019
Ellie Bowler
S
Looking for templates of Master Production Record and Master Batch record
SGquality
Aug 13, 2016
Replies
3
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5,943
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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741
Jul 9, 2019
hd designer
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National and International Business System Standards
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