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US, EU and Japanese GMPs
US, EU and Japanese GMPs
SKU:978-1-935131-30-4
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US FDA Title 21 CFR Parts:
- Part 11 - Electronic Records/Electronic Signatures (ERES)
- Parts 210/211 - CGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
- Part 820 - Quality Systems Regulations
International GMP:
- EU GMPs Chapter 1-9
- ICH Q7 - Good Manufacturing Practices for APIs
- Japanese PMDA GMP for Drugs and Quasi-Drugs - 200
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US-EU-GMP-ICHQ7-Japanese-C-251225
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