PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

Docket Number:: FDA-2003-D-0032
Issued by:: Guidance Issuing Office

Center for Veterinary Medicine

Office of Regulatory Affairs

Center for Drug Evaluation and Research

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 developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0032.

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PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

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