Table of Contents
FDA PAT Sub-Committee of Advisory Committee for Pharmaceutical Sciences June 12-13, 2002; Gaithersburg, MD Regulatory Challenges: Post-Approval PAT Applications
Outline
Need for PA-PAT Applications
Challenges in PA-PAT Applications
Challenges in PA-PAT Applications
PA-PAT Applications to APIs
PA-PAT Applications to DPs
Guidance Development for PA-PAT-based Controls CMC Review
Guidance Development for PA-PAT-based Controls Compliance Audit
Summary & Conclusions
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Author: nm21291
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