Quality Metrics Initiative

ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances based experiential and objective pilot program data.

For more information, contact RegulatoryAffairs@ISPE.org.

What are the FDA Quality Metrics

The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 provides the FDA with new authorities to ensure the safety, quality, and availability of the drug supply chain.

One section of FDASIA calls for FDA to replace the current biennial inspection of all pharmaceutical manufacturing sites with a risk-based inspection program, and provides FDA with the authority to obtain information in advance of inspection, i.e., company-supplied metrics, to support such a program.  Some of this information is quality metrics data.

“an objective set of quality metrics” would be reportable to support their risk-based inspection program choosing standardized data and metrics that would be reported.

In February 2013, the agency announced that it was exploring the broader use of manufacturing quality metrics, and began seeking feedback from industry on “meaningful” metrics to assist in the evaluation of product manufacturing quality. 

In July 2015: FDA published a draft guidance, Request for Quality Metrics which proposed the following metrics

  • The number of lots attempted of the product.
  • The number of specification-related rejected lots of the product, rejected during or after manufacturing.
  • The number of attempted lots pending disposition for more than 30 days.
  • The number of out-of-specification (OOS) results for the product, including stability testing.
  • The number of lot release and stability tests conducted for the product.
  • The number of OOS results for lot release and stability tests for the product which are invalidated due to lab error.
  • The number of product quality complaints received for the product.
  • The number of lots attempted which are released for distribution or for the next stage of manufacturing the product.
  • If the associated annual product reviews (APRs) or product quality reviews (PQRs) were completed within 30 days of annual due date for the product.
  • The number of APRs or PQRs required for the product.

In June 2016 FDA published a Technical Specifications Document, Quality Metrics Technical Conformance Guide, Version 1.0.

In November 2016 FDA published a revision to the draft guidance entitled Submission of Quality Metrics Data proposing the following metrics in an initial voluntary phase:

  • Lot Acceptance Rate (LAR)
  • Product Quality Complaint Rate (PQCR)
  • Invalidated Out-of-Specification (OOS) Rare (IOOSR)