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FDA releases Guidance on Contract Manufacturer Quality Agreements

On 22 November, 2016, the US Food and Drug Administration (FDA) finalized its long awaited Guidance on Contract Manufacturer Quality Agreements.


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. Owners and contract facilities can draw on quality management principles to carry out the complicated process of contract drug manufacturing by defining, establishing, and documenting their activities for ensuring compliance with CGMP and to ensure the quality, safety, and effectiveness of drugs.

Since the draft release in May 2013 FDA needed to clarify some special areas.

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.

Especially the terms “owner” and “contract facility” have to been defined clearly. Some commenters recommended to use “contract giver” and “contrat acceptor” instead. According to the FDA, these terms do not align with the agency’s goal of showing how the parties to a contract manufacturing arrangement can work together to define agreements.

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

  • 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

It is of particular interest to FDA 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”, the FDA emphasized.

The 16-page guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115) and represents the current thinking of FDA on Contract Manufacturing Arrangements for Drugs: Quality Agreements.


FDA: Federal Register; Contract Manufacturing Arrangements for Drugs: Quality Agreements

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