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 ...