Resources (1-9 of 9)

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

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   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

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   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

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   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

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   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

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   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

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   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. The Regulatory Landscape Regarding Continuous Manufacturing

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

8. Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing

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

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

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   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...