Finally: FDA publishes Guidance on Contracts

Recommendation

13/14 June 2023
Vienna, Austria

GMP and Quality Requirements for Radiopharmaceuticals

The US Food and Drug Administration (FDA) finalised its long awaited Guidance on Contract Manufacturer Quality Agreements. According to FDA it took this time to clarify differences between the draft from May 2013 and the final guidance.

"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.

One point being discussed was the difference between the terms "owner" and "contract facility". In some comments received it was recommended to use 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."

The FDA recommends that quality agreements should contain the following sections at a minimum:

• purpose and scope of the agreement
• terms of the agreement, including its effective dates
• terms for dispute resolution
• responsibility of each respective party
• 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 states.

To get further details please see the FDA "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry".