Skip to main content
18.97.14.83

Tags: FDA

All Categories (1-11 of 11)

  1. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

    Peer-reviewed journal | 20 Nov 2024 | Contributor(s):: Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha

    Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and...

  2. Embracing continuous manufacturing in the pharmaceutical industry

    Website | 03 Jun 2024 | Contributor(s):: Joelle Anselmo

    "Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

  3. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

    Document | 28 Mar 2024 | Contributor(s):: Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)

    The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

  4. The Process Analytical Technology Initiative: PAT and the Pharmacopeias

    Document | 28 Mar 2024 | Contributor(s):: Ajaz S. Hussain

    The PAT Initiative A part of the Pharmaceutical Quality for the 21st Century Initiative  PAT and the USP Opportunities for the USP to support the PAT Framework

  5. Implementation of ICH Q13 Continuous Manufacturing Guidance

    Workshop | 20 Nov 2023 | Contributor(s):: Rapti Madurawe

    Continuous Manufacturing (CM) BasicsICH Q13 GuidanceFDA ExperienceFuture Directions and Enabling CM of GenericsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA

  6. CDER's Emerging Technology Program

    Workshop | 20 Nov 2023 | Contributor(s):: Thomas O’Connor

    Emerging Technology Program (ETP) OverviewETP TrendsLifecycle of an Emerging TechnologyInteracting with the ETPPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing - 10/31/2023 | FDA

  7. VENKATREDDY SUNKARA

    Senior Regulatory Affairs Director with a demonstrated history of 18 years experience in Biologics/Pharmaceuticals (API & Drug Product) products registration with Global regulatory authorities...

    https://cmkc.usp.org/members/1476

  8. The Regulatory Landscape Regarding Continuous Manufacturing

    Document | 17 Aug 2023 | Contributor(s):: Adam Fisher

  9. Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing

    Document | 17 Aug 2023 | Contributor(s):: Riley C. Myers

  10. USP Workshop on Identifying and Addressing Barriers to Continuous Manufacturing Adoption

    Forum › defaultsection › general

    On July 18 and 19, over 150 professionals gathered in Rockville, MD and virtually to identify and address the barriers to adoption of pharmaceutical continuous manufacturing (PCM). Informative...

    https://cmkc.usp.org/forum/defaultsection/general/29

  11. The Changing Face of Process Development & Chemical Manufacturing - A View from the Regulators on Continuous Manufacturing

    Website | 09 Jun 2023 | Contributor(s):: Wiles, Charolotte

    Industry wide there is a drive for resource efficiency and flexibility, to adapt quickly in what is increasingly becoming a volatile, changing marketplace. As the ‘patent cliff’ looms for many high-volume API’s, there is also a shift away from blockbusters towards lower volume, higher potency...