FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013

Regulatory NewsRegulatory News | 22 November 2016 |  By 

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements.

FDA said the differences between the draft from May 2013 and the final guidance focus on areas that needed to be clarified.

“In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing activities. Although the principles articulated may be useful in approaching quality agreements for other kinds of activities, such as clinical research, development, or distribution, these are outside the scope of this particular document,” FDA said in the Federal Register.

Commenters apparently tried to differentiate between the terms "owner" and "contract facility," saying that the guidance should adopt the terms "contract giver" and "contract acceptor," though FDA said “these terms do not align with our goal of showing how the parties to a contract manufacturing arrangement can work together to define, establish, and document agreements that delineate manufacturing activities and ensure compliance with CGMP [current good manufacturing practice].”

FDA has said such quality agreements must require the manufacturer to comply with CGMP regulations, while making clear that it is ultimately the distributing entity that must ensure the products are up to par. All responsibilities for both parties should be explicitly stated in the quality agreements, FDA recommended.

Per FDA's recommendations, the quality agreements should contain the following sections at a minimum:

  • the purpose and scope of the contract agreement
  • the terms of the agreement, including its effective dates
  • terms for dispute resolution
  • responsibility of each respective party, including an overview of the subparts of the CGMP regulations
  • change control and revision practices

"From a CGMP perspective, the most critical elements of a quality agreement are the sections delineating the parties' respective responsibilities and the discussion of change control," FDA wrote.

Of particular interest to FDA is how each party will define the responsibilities of the Quality/Compliance Units, the facility and its equipment, the materials used in the manufacture of a product, laboratory controls, documentation of production, and change controls.

Final Guidance


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