Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements

This draft guidance describes FDA current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to CGMP. In particular, it describes how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. This guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products.

For further details, see FDA

Posted by Tim Sandle