Zachary Brennan of reports that the US FDA is recommending the usage of written quality agreements by pharma companies and CMOs. Although the FDA does not require such documents under cGMP (current good manufacturing practices) regulations; parties that have not complied with the recommendation have been issued warning letters.  By definition the FDA says a written quality agreement is a document outlining the responsibilities for the owners of the drug and the CMO in terms of the basic cGMP regulations. Most of these documents follow a standard form of:

  • Purpose
  • Terms (effective date and termination clause)
  • Dispute resolution
  • Responsibilities, including communication mechanisms and contacts
  • Change control and revisions

The FDA is also offering case studies for situations where a quality agreement does not exempt a CMO’s facility from cGMP requirements. Overall, The FDA is using written quality agreements to reduce the likelihood of misinterpretation and error from the manufacturing process. Read the full article here.