Quality Metrics


On July 28, 2015 the FDA posted the draft guidance on Request for Quality Metrics for public comment.  Industry has 60 days from the publication date in the federal register to submit comments.  The public comment period will end on September 28, which means there are approximately 3 weeks remaining to review the draft and provide your comments.

FDA is seeking to request the following 10-data points from industry:

  • 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.

Using this data the FDA will calculate the following four quality metrics (in addition with other data available to FDA) to ascertain operational reliability, the company’s quality culture, the potential for drug shortages, and compliance/inspection policies and practices:

  • Lot Acceptance Rate = 1 – x (x = the number of specification-related rejected lots in a  timeframe divided by the number of lots attempted by the same establishment in the same timeframe).
  • Product Quality Complaint Rate = the number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe.
  • Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe.
  • Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate = the number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

As of today do your quality systems support automated data collection and retrieval of the above 10-data points? if not, will you seek to add new functionality to an existing automated system to provide this data?  Will you seek to add a new automated system in order to comply?  Or will you resort to adding headcount or contractor support in manually pulling the data from the GMP library, followed by manual counting in order to comply once the regulations become final? Will you establish SPC Control charts to monitor these 10-quality driven data points?