US FDA Recommends CMO Quality Agreements in Long-Awaited Draft Guidance

28-May-2013 - Last updated on 29-May-2013 at 07:08 GMT

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Although written quality agreements are not required under cGMP regulations, the US FDA is recommending that pharma companies and CMOs adopt the agreements to delineate responsibilities.

The FDA defines a written quality agreement as a document outlining the roles and responsibilities for the owner of the drug and the CMO (contract manufacturing organizations) in terms of the basic cGMP (current good manufacturing practices) regulations. Clear language should define quality roles, establish expectations, specify the transfer of services or products between the companies and establish which party will have final approval of the end result, according to the FDA draft guidance.

And although quality agreements are not an FDA requirement, the agency has issued warning letters for pharma companies that fail to set up such an agreement.

The agency says most quality agreements contain the following basic sections:

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

Drug companies may consider adopting the terms and procedures used by CMOs in order to “reduce the likelihood of misinterpretation and personnel error during actual manufacturing,” the FDA says.

A communication plan that explains how manufacturing deviations will be outlined to the drug’s owner by the CMO, as well as how such deviations will be investigated, documented and resolved, should be included in an agreement, the FDA says.

“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,” the FDA notes.

Case Studies

The FDA offers case studies in situations where a quality agreement does not exempt a CMO’s facilities from cGMP requirements, regardless of whether those requirements are outlined in the quality agreement.

The FDA says the lesson from such cases is that CMOs “should insist on greater clarity regarding how [drug] Owners will carry out specific obligations under the Quality Agreement, because the Quality Agreement will not serve as an excuse for manufacturing drugs in a non-compliant environment.”

Two other case studies are also included on circumstances when contracted laboratories are considered contracted facilities and therefore subject to cGMP requirements.

“Contract Laboratories are Contracted Facilities like any others, and they are responsible for complying with CGMPs that relate to the operations they perform, regardless of the specific terms of any Quality Agreement they have reached with the product Owner,” the FDA notes.

Comments on the draft guidance are due by July 29.