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GMP International Master Reference

GMP International Master Reference

978-1-935131-37-3

$36.95
$36.95
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Over 900 pages of GMP guidance and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian, Chinese and Japanese 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

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GMPInternMaster-C-251218
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