GMP Publications - Code of Federal Regulation Handbooks by the FDA

US, EU and Japanese GMPs

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978-1-935131-30-4

US FDA Title 21 CFR Parts

21 CFR Part 11 - Electronic Records/Electronic Signatures (ERES)
21 CFR Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
21 CFR Part 820 - Quality Systems Regulations

EU GMPs Chapter 1-9

ICH Q7 - Good Manufacturing Practices

Japanese GMP for Drugs and Quasi-Drugs - 2005



















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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 and Japanese!

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