FDA Issues Draft Guidance on Contract Manufacturing Agreements

FDA just issued the draft guidance document: Contract Manufacturing Arrangements for Drugs: Quality Agreements.  Comments are due to FDA by July 29, 2013.

The guidance “describe[s] FDA’s current thinking on defining, establishing, and documenting the responsibilities of each party involved in the contract manufacturing of drugs and how they can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”  The guidance refers to Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10), that currently address quality management of contract manufacturing organizations by the “Product Owner.”

The following sections should form the basis of a Quality Agreement.  FDA feels that 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.  MWA feels that terminology is also a critical component to the quality agreement, as we have seen where the CMO identifies a Major deviation very differently from the Product Owner, and this causes delays in product release and can even lead to product rejection by the Product Owner.

  • Purpose/Scope
  • Terms (including effective date and termination clause)
  • Dispute Resolution
  • Responsibilities, including communication mechanisms & contacts
  • Change control and revisions
  • Definitions or Common Terminology

Read the guidance here.