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Fifth Edition GxP Regulations Series 2015
These highly successful guides have been painstakingly updated to provide the user with a roadmap to Good Practices comprehension while providing insight into regulatory compliance expectations.
- A comprehensive collection of Good Practices for clinical, laboratory and manufacturing
- Updated text and references to the latest guidance documents from FDA, EMA, ICH, Health Canada, WHO, PMDA-Japan and others
- Detailed comparisons of U.S., European and Japanese Good Practice documents, definitions and regional differences
- Extensive document templates and examples
- Regulatory inspection preparation, survival and response
- Multiple checklists to ensure compliance with document requirements
Included in this series:
Good Clinical Practices: Guide to Compliance Hard Copy | PDF
Good Laboratory Practices: Guide to Compliance Hard Copy | PDF
Good Manufacturing Practices: Guide to Compliance Hard Copy | PDF
GXP Guides Series Hard Copy | PDF