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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
Sticky
Websites - Medicines Regulatory Authorities (global)
Ajit Basrur
Jan 2, 2012
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0
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4,136
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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5,449
Jul 20, 2011
Ajit Basrur
Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Marc
Oct 18, 2009
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4,737
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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6,966
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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21,322
Apr 22, 2008
Scott Catron
Discussions
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Communication plan according to ISO9001 - Pharmaceutical field
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Mar 1, 2012
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Jun 26, 2015
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May 15, 2019
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Site Master File for multiple business units within same premises/facility
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Jul 5, 2016
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May 15, 2019
Marc
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Jan 15, 2019
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May 15, 2019
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Release testing for Combination Drug-Medical Device
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May 13, 2019
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HVAC System vs Air Handling Unit (AHU) - Differences
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Pharmaceuticals Warehouse temperature control (room temperature)
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Apr 23, 2019
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Apr 26, 2019
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ISO 7 Clean rooms - Are sinks, faucets, floor drains etc. allowed?
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285
Feb 5, 2019
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FDA filing guidance to add sterilization step for approved drug
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Additional Controls for processing the raw data on different computers (processing system)
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European Pharmacopoeia First Identification Requirements
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Jan 9, 2018
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1,491
Dec 31, 2018
v9991
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