FDA Draft Guidance: Manufacturing Arrangements for Drugs – Quality Agreements, 5/13

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In May 2013, the FDA issued this draft of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements. Upon approval, this document will provide guidance regarding the contents of contract manufacturing Quality Agreements and delineation of responsibilities for companies involved in commercial manufacturing of Active Pharmaceutical Ingredients, finished drugs, combination products, and biological drug products.

Note that for the purposes of this document, ‘manufacturing’ includes processing, packing, holding, labeling, testing, and the operations of the Quality Unit.

For information specific to software and computer systems, see sections:

• IV.B.1.bﾠ Responsibilities for validation, including information technology
• IV.B.1.dﾠ Storage and retention of electronic records