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GUIDANCE DOCUMENT

PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance Guidance for Industry September 2004

Final

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

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.