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New Quality Office Needed to Link Preapproval Work to GMPs, FDA Officials Say


CDER’s proposed new Office of Pharmaceutical Quality (OPQ) is needed to promote good manufacturing practice (GMP) standards in the preapproval setting — standardizing GMP assessments throughout a drug’s life cycle.

While the entire scope of the proposal is still developing, FDA speakers at the 2012 Parenteral Drug Association/FDA Joint Regulatory Conference here said the standardization is one key driver behind the idea for the office, which would likely place reviewers and compliance staff under the same office.

Currently, “to some extent, industry is having to deal with inspection and review separately, so linking them would allow the agency to speak in one voice on quality to the benefit of industry and the public health,” Russell Wesdyk, a CDER scientific coordinator, said.

A broadened definition of GMP that will give the agency greater control over a company’s suppliers is one of many changes that occurred with the latest installment of the Prescription Drug User Fee Act (PDUFA), passed by Congress earlier this summer.

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