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# Guide on CMO Quality Agreements
- URL: https://www.fdaweb.com/guide-on-cmo-quality-agreements/
- Published: 2016-11-23T12:00:00.000Z
- Updated: 2026-09-14T21:50:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137416

*Federal Register* Notice: FDA has made available a guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The document describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current GMP requirements. Specifically, it describes how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure GMP compliance. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-23/pdf/2016-28122.pdf?ref=fdaweb.com).