FDA Guidance for Pharmaceutical CMO Quality Agreements

Quality agreements are critical to ensure you and your contract manufacturer define each other’s roles and responsibilities with respect to quality. On November 22, 2016, the FDA released the finalized guidelines that specify what should go into quality agreements between pharmaceutical companies and outsourced contract manufacturers.

This guidance applies to commercial manufacturing for human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products.

It does not apply to Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271.

Download the guidance here.