FDA to Tackle Manufacturing Quality Issues Early in Premarket Reviews

Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line.

Under a new review approach, drugmakers will be assigned a specialized team, rather than a single review official, that will examine the proposed product for potential quality problems, among other things, before companies put in place manufacturing facilities for the drug.

The review team, comprised of FDA experts in drug substances, formulations and manufacturing processes, also will include the investigator who will ultimately inspect the facility for preapproval, giving the company and the investigator an opportunity to work out manufacturing compliance concerns in advance of inspection.

CDER Director Janet Woodcock detailed the new methodology at the 2014 Parenteral Drug Association/FDA Joint Regulatory Conference in Washington, D.C.
The new approach is part of the agency’s ongoing effort to foster a culture of quality in manufacturing facilities.

Woodcock noted that the agency can’t mandate or create such a culture. But she warned that even though manufacturing issues such as long cycle times, poor process capability, high inventories and high waste don’t violate agency regulations, they do have consequences that can lead to substandard products entering the market.

The agency is hoping to take a more proactive approach to identify such problems and help manufacturers prevent them before they affect product quality, Woodcock said. The initiative is currently under development.

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