New FDA quality office to grade manufacturing operations

The FDA has shared details of plans for its Office of Pharmaceutical Quality (OPQ). Staffers plan to group drug production operations by category and release an average quality grade for each bucket, allowing manufacturers to see if they are outperforming their peers.

Lawrence Yu

OPQ deputy director Lawrence Yu outlined the plan in an interview with Pharmalot. As with several aspects of OPQ, the details of the approach are still being ironed out, but the basic idea is in place. Yu compared the plan to how teachers share the average scores from exams to show students whether they are doing better or worse than their peers. FDA would do a similar thing by collating, averaging and sharing elements of its metrics.

The FDA has no plans to publish details of specific manufacturing plants or product lines, but will release the average from across certain groups, such as producers of modified-release dosage forms or small molecules. Collating manufacturers will increase the validity of comparisons by lessening the impact of inter-class differences. If a biologics manufacturer's grade is well below the average, they will know it is not just because such products are tough to produce.

Many details of the plan could change between now and when it is finalized. Yu hopes to publish draft guidance on the metrics the FDA will use this year--it is on the list of planned releases for 2015--but the document has been delayed in the past. "We certainly wished we issued guidance even in 2013. But we're part of the government and we need to get input from stakeholders before we issue a guidance," Yu said.

- read the Pharmalot interview

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