Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production - Hardcover

Inhaltsangabe

This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process! Within this book, you can find chapters on: ~ Current manufacturing and process development of Regenerative Medicine Advanced Therapy Products (RMATs), or as they are known in the EU, Advanced Therapy Medicinal Products (ATMPs) ~ Quality systems and GMP requirements for Phase 1 to Phase 3 manufacturing ~ The impact of the Clinical Trials Directive on European GMP expectations and the role of the QP ~ The latest USP guidance on the transfer of analytical methods, validation and verification of compendial procedures ~ And, much more

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