GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP International Master Reference Guide

GMPInternationalMasterReferenceGuide.jpg
978-1-935131-37-3

Over 900 pages of GMP guidances and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian and Japanese!

Includes:

US FDA Title 21 CFR Parts

Part 11 Electronic Records; Electronic Signatures with scope & Application
Part 11 - Auditor's Check List
Part 58 - Good Laboratory Practice
Part 111 - Dietary Supplements GMPs
Parts 210/211 Drug GMPs
Parts 210/211 Drug GMPs - Auditor's Check List
Part 820 Quality Systems Regulations
Part 820 QSR - Auditor's Check List
ICH Q7 Active Pharmaceutical Ingredients (APIs)
ICH Q7 - Auditor's Check List
ICH Q8 - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH Q10 - Pharmaceutical Quality System
EU GMPs Chapter 1 – 9
Canadian GMPs 2009 Edition GUI-0001
Japanese GMPs

 





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