ISPE Launches Quality Metrics Pilot Program

The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program.

The pilot will be open to approximately 15 sites that manufacture various product types such as solid oral and sterile drugs, ISPE said. The sites will also represent branded, generic and OTC products to ensure statically meaningful findings, said the group, which has a membership of more than 22,000 pharma quality officials and technical experts.

“The pilot also will take into account a sampling from large molecule sites to test the feasibility and applicability of data definitions and collection,” the ISPE said.

The sites will collect data on six metrics the group recommended earlier this year, such as batch rejection rate, confirmed out-of-specification rate and critical complaint rate.

The pilot program could include additional metrics proposed by ISPE or other parties, spokeswoman Danielle Hould said March 13.

Manufacturing sites in the pilot will report data to a third party. ISPE will then analyze the blinded, aggregated data, Hould said.

The quality metrics are intended to be a critical part of the FDA’s risk-based inspection push, a mandate of the FDA Safety and Innovation Act. The agency intends to use metrics data to determine the inspection frequency for sites in lieu of biennial inspections.

Eventually, the FDA plans to provide companies with individual rankings on how they stack up against their peers. What the agency will collect remains up for debate, although officials have said they plan to collect no more than 16 metrics.

The ISPE plans to launch the pilot this June during its annual current good manufacturing practices conference in Baltimore, Md.

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