REGULATORY WG
Regulatory Working Group for Continuous Manufacturing
UPDATE: Posted for public comment on June 23, 2017 - https://www.regulations.gov/document?D=FDA-2017-N-2697-0001
This document is developed in response to an FDA invitation to prepare and submit a proposal for an industry coordinated best practices document in Continuous Manufacturing, issued by Dr. Janet Woodcock during the workshop on “the Future of Pharmaceutical Manufacturing” held at Rutgers University on May 7, 2015.
This document, which has been drafted by C-SOPS regulatory working group involving 22 volunteers from 16 companies, and which incorporates input from RCPE and CMAC member companies, attempts to capture the current scientific and regulatory understanding of the best available methodologies for selecting, specifying, implementing, controlling, and optimizing continuous drug product manufacturing systems for solid oral dosages from the group assembled in response to the above invitation. This document is not intended to be prescriptive, and individuals looking to implement the technology described herein are encouraged to engage regulatory agencies (FDA/EMA) early in their adoption process as mentioned in the Draft Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry1.
The focus of this document is on U.S. FDA, innovator and generic drug product manufacturers, and solid oral dosage forms only.