Quality Agreement for Drug Product Manufacturing

Summary

This template Quality Agreement can be used as a reference when drafting or negotiating a drug product manufacturing arrangement between a drug company (also referred to as the owner in the drug manufacturing context) and a contract manufacturing facility. Key issues include U.S. Food and Drug Administration (FDA) Current Good Manufacturing Practices (cGMP) compliance, quality control/assurance, product/process validation, and reporting responsibilities. This template includes practical guidance and drafting notes. This template Quality Agreement assumes the existence of a Master Service Agreement (MSA) for drug manufacturing services between the drug company and the manufacturer. The use of a quality agreement in conjunction with a drug manufacturing MSA is a best practice in line with FDA regulations and guidance, including 21 C.F.R. § 211.22(d). It is worth noting that the FDA may review a quality agreement as part of its inspection of either party’s facilities. For additional information about FDA regulation of drug manufacturing and other drug life cycle events, see FDA Regulation of Pharmaceuticals. For information about FDA quality control matters including facility inspections, see Responding to Form 483 Inspection Observations. To compare state laws on licensing for a variety of healthcare professionals, see the Nonphysician Practitioners Licensing, Hospital Licensing, Pharmacist Licensing, Pharmacy Licensing, Physician Licensing, and Pharmacy Benefit Manager (PBM) Licensing and Registration Laws topics in the Life Sciences section of the State Law Comparison Tool . For more information see International Pharmaceutical Law and Practice. For additional guidance, please see Quality Agreement for Drug Manufacturing Checklist and Master Service Agreements. For caselaw on this topic see In re Digitek Prods. Liab. Litig., 2009 U.S. Dist. LEXIS 113947 and United States v. Richlyn Labs., Inc., 822 F. Supp. 268.