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  1. 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

  2. A Perspective on Quality by Design: A Preclinical Opportunity

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

  3. A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative

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

  4. The Subcommittee on Process Analytical Technologies (PAT): Closing Remarks

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

  5. 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

  6. Utilizing PAT to Monitor and Control Bulk Biotech Processes

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    Document | 27 Mar 2024 | Contributor(s):: Rick E. Cooley

    1.What is and isn’t PAT? 2.Implementing PAT in Manufacturing: What does it take? 3.Characteristics of bulk, biotech API processes 4.Why PAT? 5.Review of PAT technologies utilized 6.PAT application examples

  7. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

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    Document | 09 Jun 2023

    This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has...

  8. Effective Development of PAT Capability in Pharmaceutical Manufacturing

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    Document | 09 Jun 2023 | Contributor(s):: Hammond, Steve

    Over the last ten years, the path to effective development of PAT has evolved, driven by the advent of continuous manufacturing. The development and deployment of PAT used for pharmaceutical manufacturing has arrived at a point where application development has been miniaturized and streamlined....