SBIA Chronicles: An FDA Self-Audit of Continuous Manufacturing for Drug Products

CDER's OPQ conducted a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes.

Receive this email as a forward? Subscribe to CDER SBIA industry updates. An FDA Self-Audit of Continuous Manufacturing for Drug Products Listen to the audio podcast Mahesh Ramanadham, Commander, U.S. Public Health Service; Deputy Director - Office of Policy for Pharmaceutical Quality | Office of Pharmaceutical Quality CDER | FDA       Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER's Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval. CM is an advanced manufacturing technology that sends materials produced during each process step directly and continuously to the next step for further processing, whereby input materials are continuously fed into production and transformed, and processed output materials are continuously removed. In this self-audit, OPQ analyzed time to approval and market entry, manufacturing process changes reported in Annual Reports, manufacturing-related post-approval application supplements, and pre-approval inspections. At the start of 2022, there were six approved applications that utilized CM for their finished solid oral drug products. One application's product is approved to be made by either a batch or CM process, by the same firm. OPQ used a set of 134 approved comparator products manufactured using batch operations and meeting certain criteria, and made comparisons based on additional subsets of this dataset.   Read the full article here Resources 1. Fisher AC et al., An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. Int J Pharm. 2022; 622:121778 2. FDA's Emerging Technology Program 3. Draft Guidance for Industry: Quality Considerations for Continuous Manufacturing 4. Draft Guidance for Industry: Q13 Continuous Manufacturing of Drug Substances and Drug Products Upcoming Events 1. Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites- July 19-20, 2022 2. Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use - August 10, 2022 3. Best Practices for Topical Generic Product Development and ANDA Submission - August 11, 2022 Cheers, Renu Lal, Pharm.D. CDER Small Business and Industry Assistance   Issues of this newsletter are archived at http://www.fda.gov/cdersbiachronicles   This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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