FDA GUI Summary of Contract Manufacturing Arrangement for Drugs: Quality Agreements November 2016 www.Rx-360.org This summary was prepared by the Rx-360 Monitoring and Reporting Working Group which tracks regulatory, legislative and policy developments relevant to pharmaceutical/medical device supply chain integrity. The summary is not intended to serve as comprehensive and formal interpretation or guidance (and should not replace your own review and analysis of any referenced source documents). If you have questions, please contact Britany Tobery, Rx-360 Secretariat, at 301.710.9399 or btobery@rx-360.org

I. Guidance Purpose and Scope The guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to CGMP requirements. Specifically the guidance outlines how the drug’s owner and the contact drug manufacturer should draft the content of a quality agreement to delineate their manufacturing activities to ensure compliance with CGMP. Pertains to commercial manufacturing of human and veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products. Does not pertain to Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271. www.Rx-360.org

II. Defining the Who and What of Contract Manufacturing Describes how contract manufacturing operations fit within the larger scheme of pharmaceutical quality systems Addresses the relationship (roles & responsibilities) between owners and contract facilities Define owners as manufacturers of APIs, drug substances, in-process materials, finished drug products, including biological products, and combination products.

III. Responsibilities of Parties Involved in Contract Manufacturing FDA encourages parties engaged in contract manufacturing to implement quality management practices. This guidance is intended to build upon the quality risk management principles and recommendations outlined above and to illustrate key points in developing and executing quality agreements that describe and support contract manufacturing arrangements. Recommends the use of guidance provided in ICH Q7,Q9, Q10.

IV. Documenting CGMP Activities in Quality Agreements 21 CFR 211.22(d) states that quality unit activities and procedures should be in writing. FDA recommends that owners and contract facilities establish a written quality agreement to describe their respective CGMP-related roles, responsibilities, and activities in drug manufacturing. Quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP. Provides a definition of a Quality Agreement and a brief explanation of each of the activities to cover: manufacturing, quality unit, facilities and equipment, materials management, laboratory controls, documentation, change control, and product distribution.

VI. Recommendations Owners and contract facilities should apply quality management principles to carry out the complicated process of contract drug manufacturing by defining, establishing, and documenting their activities in drug manufacturing operations, including processing, packing, holding, labeling operations, testing, and quality control operations. FDA recommends that owners and contract facilities implement written quality agreements as tools to delineate manufacturing activities for ensuring compliance with CGMP.

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