This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.
Keywords: GMP; ICH; bioequivalence; continuous manufacturing; control strategy; processing; regulatory considerations; stability; unit operations; validation.
© 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.