GMP International Master Reference Guide

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(R2) - Pharmaceutical Development
- ICH Q9(R1) - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- EU GMPs Chapter 1 - 9
- Canadian GMPs Edition GUI-0001 - July 2020
- Japanese GMPs
- Added - Chinese GMPs Decree 79 English