FDA Issues Final Version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements

In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements. The guidance applies to commercial manufacturing of human and veterinary drugs, certain combination products, biological and biotechnology products, finished products, active pharmaceutical ingredients, excipients, in-process materials and drug constituents of combination drug/device products. Among other things, this final version clarifies that, although the principles articulated in the guidance may be useful in approaching quality agreements used for activities like clinical research, development, or distribution, the scope of this particular guidance is limited to commercial manufacturing activities.