FDA Releases Guidance on Quality Agreements for Contract Manufacturing

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” This guidance describes FDA's current thinking on defining, establishing, and documenting the responsibilities of each party involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, the guidance describes how parties involved in the contract manufacturing and quality control of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. The guidance can be viewed and downloaded from the FDA website.