GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP International Master Reference Guide

GMPInternationalMasterReferenceGuide
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, Japanese and Chinese GMPs!

Includes:

US FDA Title 21 CFR Parts:

- Part 11 Electronic Records; Electronic Signatures
- Part 11 Scope and Application 2003
- 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

Guidance:

- 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 Edition GUI-0001 - October 2018
- Japanese GMPs
- Added - Chinese GMPs Decree 79 English

 

 

 

 

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