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# Contract Manufacturing Quality Agreement Guidance
- URL: https://www.fdaweb.com/contract-manufacturing-quality-agreement-guidance/
- Published: 2016-11-22T12:00:00.000Z
- Updated: 2026-09-14T21:50:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137404

FDA has issued a guidance, *Contract Manufacturing Arrangements for Drug: Quality Agreements*, with the agency’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice requirements. In particular, the [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf?ref=fdaweb.com) says, “we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.”

The guidance covers commercial manufacturing of human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, active pharmaceutical ingredients, drug substances, in-process materials, and drug constituents of combination drug/device products.