FDA Strengthens Guidance on Quality Agreements with CMOs

Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what drug companies must do to ensure that their agreements with CMOS are clear and enforceable.

In a final guidance issued, the FDA expanded the elements that should be included in most quality agreements. Specifically, the FDA says these agreements should include:

• The purpose/scope, which would explain the contract manufacturing services to be provided;
• Definitions, which would provide the precise meaning of terms in the quality agreement;
• Resolution of disagreements, which would explain how the parties will resolve disagreements about product quality issues or other problems; and
• Manufacturing activities, which would document quality unit and other activities related to manufacturing processes and the control of changes; and
• The life cycle of and revisions to the quality agreement.