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GUIDANCE DOCUMENT

Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry Guidance for Industry November 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0558
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their
manufacturing activities to ensure compliance with CGMP.
 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2013-D-0558.

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