Details Come Forth on Phase Two of ISPE’s Quality Metrics Pilot Program

ISPE’s quality metrics team has settled on 13 metrics that it will ask drugmakers to collect data on during the second phase of a pilot program meant to help the FDA boost quality compliance.

The metrics include eight that measure quality of the manufacturing process and five that measure a company’s quality culture — nearly as many as in round one. Following a review of the pilot’s first phase, the team identified a “starting set” of five metrics for inclusion in any industry quality metrics program. The final list includes these five, as well as others ISPE feels could be useful in gauging the strength of a company’s quality system.

The eight quality metrics for phase two are:

• Total complaints rate;
• Critical complaints rate;
• Recall events;
• Lot acceptance rate;
• Invalidated out-of-specification rate;
• Right first time rate;
• Deviations rate; and
• Recurring deviations rate.

Of those, lot acceptance rate and critical complaints — both at the product and site level — and deviation rate are considered the most paramount, ISPE says.

The five culture indicators are:

• CAPAs with preventive actions;
• Planned maintenance;
• Employee turnover;
• Human error deviations; and
• Deviations with no assigned root.

Phase two will also include two survey-based metrics, one on quality culture and the other on process capability, as well as a “placeholder” metric in case the FDA decides to release a quality metric guidance in the near future, ISPE says.

Seven metrics from the first phase — confirmed, stability, and incoming materials out-of-specification rates, APQR reviews completed on time, CAPA effectiveness rate, and media fill and environmental monitoring for sterile aseptic sites — have been dropped in phase two because no correlations or outcomes were gleaned from them, ISPE says.

The group revealed details of the next phase of its Quality Metrics Pilot Program at the ISPE/FDA/PQRI Quality Manufacturing Conference in Washington, D.C.

The second phase will continue to refine the set of “critical few” metrics identified in phase one and work to develop a possible industry lead “work space” for common metrics standards and benchmarking. Enrollment begins next week, with data collection running from July to November.

Participating companies will submit either one-year or two-year data on all their products to allow for an examination of trending patterns. At the same time, firms will gather data on two to five products, beginning at the application level, so that McKinsey & Company, which is analyzing the data for ISPE, can assess the effort needed to compile large quantities of data.

Phase two will also focus on verifying data and establishing data submission processes that mimic those companies would use to submit data to the FDA — a feature not included in the first phase of the pilot program.

ISPE also hopes to add more sterile and API manufacturers and firms from Asia and Latin America, as it looks to aggregate data across all sectors, diversity being a top priority for the program. Companies that are able to supply data across the supply chain and those with stand-alone labs are also encouraged to participate.

Companies wishing to participate or get more information can contact ISPE at PQLI@ispe.org. — Kellen Owings