The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

ISPE Recommends Six Site Quality Metrics and Definitions

Jan. 17, 2014

The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program.

ISPE, with industry representation of more than 22,000 pharma quality officials and technical experts, began working with its members to develop the recommendations in November. The six metrics it chose are:

  • Batch rejection rate, defined as “any decision indicating that the batch didn’t meet FDA product regulations”;

  • Rework and reprocessing rate — actions taken on a nonconforming product so that it will fulfill the specified requirements before release;

  • Confirmed out-of-specification (OOS) rate, based on all test results that fall outside the specifications or acceptance criteria;

  • Unconfirmed OOS rate, “an OOS result which is found after investigation not to be a confirmed OOS,” ISPE said;

  • Critical complaint rate, composed of confirmed complaints that a product failed to meet specifications, could impact patient safety and/or result in a drug recall; and

  • Percent of annual product quality reviews completed on time per the FDA’s definition in its good manufacturing practice regulations.

The list largely conforms with metrics recommended late last year by a group of more than 300 drugmaker quality representatives.

Within the next two years, the FDA will require industry to provide data from no more than 16 product and site quality metrics as part of its move to a risk-based inspection system. The agency has been collaborating with industry to determine appropriate metrics, and intends to provide drugmakers with individual rankings that will show how their companies’ quality systems stack up against their peers.

ISPE strongly recommended against setting any numerical targets for metrics, saying the industry is too varied — with some sites manufacturing multiple types of products — to measure against a specific number.

Putting numerical targets could also create complacency, ISPE said. “If a certain rejection rate is defined as ‘acceptable,’ sites meeting that target might not have the incentive to look holistically for potential opportunities for quality and compliance improvements,” ISPE said in announcing its recommendations.

There are many quality metrics to which you need to pay attention. Find out what else you need to know with Secrets of FDA Drug and Biologics Inspection Preparation.