Supplier Quality Declines, FDA Considers Guidance on Manufacturer Responsibilities in Outsourcing

The FDA may soon issue agency-wide guidance to clarify drug and device manufacturers ’ responsibilities for the quality of ingredients manufactured by contractors, agency officials say.

“We do feel there is a need for more clarity on our current expectations” for contract manufacturing organizations (CMOs), Richard Friedman, associate director in CDER’s Office of Manufacturing & Product Quality recently told QMN. And in an interview with QMN this week, CDER Director Janet Woodcock confirmed the agency is evaluating what it can do to improve supply chain management. Those changes most likely would be made through “legislation or regulation.”

Supplier quality has made the ‘Top 10’ in Form 483 observations and that’s “pretty significant,” especially since many drugmakers moved to outsourcing as a way to cut costs, notes Steve Niedelman, an ex-FDAer now with law firm King & Spalding. Indeed, the number of warning letters citing supplier quality issues has risen yearly since 2008, he says. And FDA is starting to ask manufacturers for their supplier agreements.

Just look at Gulf Medical Fiberoptics. FDA investigators said in a recent Form 483 that the company’s supplier evaluation form doesn’t ensure validation of the vendor’s ability to meet quality requirements, plus the company didn’t follow its own stated requirements to evaluate and select contractors.

Because outsourcing has become the norm, industry needs more mature external supplier management and risk management regimens that assure customers consistently get quality products and services from contract manufacturers, Niedelman says.

Do your CMOs meet quality standards? They should. You can be proactive and make certain your company is setting quality standards — and your CMOs are meeting them — before you have to hustle to comply with legislation or more FDA regulations.

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