FDA Embarks on Quality Metrics for Production Sites to Assess the State of the Quality System

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In 2015, FDA is going to be asking production sites to provide data about the “quality level” in the manufacturing site. By this, FDA will be able to see from the data how well the quality system is maintained and how successful the quality system will affect the quality of the drug products.  FDA intends to use these metrics as part of a learning period.  Expect to see a new draft guidance on Quality Metrics to be issued by FDA in 2015.  Below are the manufacturing metrics of potential interest to FDA.

  •  Lot Acceptance Rate = 1 – (the number of lots rejected by the establishment in a year divided by the number of lots attempted by the same establishment in the same year.
  •  Right First Time Rate = 1 – (the number of lots with at least one deviation by the establishment in a year divided by the number of lots attempted by the same establishment in the same year.
  •  Product Quality Complaint Rate – the number of complaints received by the manufacturer of the product concerning any actual or potential failure of a unit of drug product to meet any of its specifications, divided by the total number of lots released by the manufacturer of the product in the same year.
  •  Invalidated Out-of-Specification (OOS) Rate – the number of OOS test results invalidated by the establishment, or contracted establishment in a year divided by the total number of tests performed by the establishment in the same year.

Cultural Metrics of Potential Interest to FDA

  •  Management Engagement – the most senior manager that signed each annual product review, reported as one of the following: (1) none specified, (2) line quality manager, (3) site operations manager, or (4) corporate executive manager.
  •  Annual Product Review (APR) on Time Rate – the number of APRS generated within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

 –   Performance Question 1: A “yes” or “no” value of whether the establishment calculated a process capability or performance index for each critical quality attribute as part of that product’s APR.

–   Performance Question 2: A “yes” or “no” value of whether the establishment has policy requiring a CAPA at some lower process capability or performance index.

–   Performance Question 3: If “yes” to question 2 – what is the process capability or performance index that triggers a CAPA. If “no” to question 2 – please do not respond.

  •  Corrective and Preventative Action (CAPA) Rate – the number of corrective or preventative actions that were initiated, divided by the total number of APRs generated.

Download the presentation, CDER’s Quality Metric Initiative.