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

PDA recently published a book 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. RCA’s Sue Schniepp authored Chapter 8: Deviations, Change Control, Process Improvements. Other chapters include:

 

  • 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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