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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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5,820
Jan 2, 2012
Ajit Basrur
Sticky
ICH Guidelines - Quality, Safety, Efficacy and Multidisciplinary
Ajit Basrur
Jul 20, 2011
Replies
0
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7,496
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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6,368
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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8,919
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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23,220
Apr 22, 2008
Scott Catron
Discussions
E
21 CFR 211.103 Calculation of Yield
emorin
Jun 10, 2020
Replies
5
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305
Jun 12, 2020
Marc
Q
Serialization and Reconciliation of Forms
qualitytam
May 5, 2020
Replies
7
Views
381
May 14, 2020
Jean_B
Q
Project Tracker - Something that shows the status of each project
qualitytam
May 5, 2020
Replies
1
Views
201
May 8, 2020
John Broomfield
E
Non-GMP examples in Pharmaceutical industry
elsmargirl2020
May 8, 2020
Replies
2
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251
May 8, 2020
elsmargirl2020
L
Wearables 21 CFR Part 11 compliance
Lily11
Mar 3, 2020
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1
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531
Mar 3, 2020
yodon
K
Validation of new machine (second machine of the same type)
Kid006
Jan 22, 2020
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2
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515
Jan 22, 2020
Kid006
M
Can a PLD Registered in only one state sell prescription drugs to one in another state
me too
Dec 24, 2019
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0
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421
Dec 24, 2019
me too
C
Security and access in cGMP facilities
ChemistAnalytical
Dec 17, 2019
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1
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372
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
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3
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766
Dec 17, 2019
QHawk
C
Sterility and Bioburden Testing - LAL passed under 0.5EU/mL
Cleslie22
Nov 12, 2019
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3
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595
Nov 13, 2019
planB
D
What is the best software used for the pharma compliance management?
duckdonald
Sep 26, 2019
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574
Sep 26, 2019
duckdonald
E
Unit Dose Packaging
Elleder
Sep 11, 2019
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460
Sep 11, 2019
Elleder
C
Locked
Raw material Mixing / Preparation for clean room class C injection molding
chemist_tma
Sep 10, 2019
Replies
1
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507
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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500
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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574
Aug 1, 2019
Ronen E
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National and International Business System Standards
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