The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) is making clear in its public presentations, compliance actions, and guidance to industry that the relationship between contract manufacturers and product owners – and the quality agreements they have in place to facilitate this relationship – will be a key focal point during CGMP inspections.
Building on FDA’s release in December 2016 of a final guidance to industry on quality agreements, compliance officials have been highlighting at recent conferences the increasing emphasis this relationship has been getting during inspections of both product owners and contract manufacturers, as well as the serious quality problems that these inspections have been revealing when it is not viable.
The contracting relationship was a focal point, for example, in the keynote presentation by OC Office of Manufacturing Quality (OMQ) Director Thomas Cosgrove at the ISPE/FDA/PQRI Quality Manufacturing Conference in June.
OMQ is responsible for evaluating drug CGMP compliance, based on what investigators are uncovering and other sources, and for developing and implementing compliance policy, enforcement strategy, and actions deemed necessary to protect the public health.
In providing an update on FDA’s current drug compliance concerns and activity at the conference, Cosgrove highlighted the criticality of the owner/contractor relationship. He noted that his office has been directing field investigators “to be particularly mindful of the state of quality agreements” – and especially so when inspecting the contract manufacturing organization.
“We are taking the relationship between the manufacturers and sponsors quite seriously,” the compliance official stressed, and “we are looking closely at the quality agreements” during inspections.