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Focusing on enhancing pharmaceutical product quality, this comprehensive guide offers detailed instructions and practical tools for compliance with global regulatory standards. It includes standard operating procedures, checklists, and templates for easy laboratory integration. The book elaborates on developing validation strategies for various analytical methods and covers the qualification process for equipment, software, and personnel. Additionally, it provides insights into internal and third-party laboratory audits and inspections, making it an essential resource for industry professionals.
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Validation and Qualification in Analytical Laboratories, Ludwig Huber
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- Pubblicato
- 2007
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