Document (1-6 of 6)

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