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New Guidance issued by FDA on Quality Metrics

Berkshire Sterile Manufacturing


On September 9th, 2016 FDA released a technical reference document aimed at quality metrics in process validation and the pharma quality systems. The goal of this document, per the FDA, is to make regulatory reviews and inspection process/policies more clear for FDA-regulated companies. The FDA is requiring companies to establish a risk-based approach to review and to look at quality metric reporting. The changes hope to improve uniform assessment of manufacturing and product quality in response to unique quality issues found at different companies.


They are looking for feedback on the following metrics:

  • Product quality complaints received for product distributed in the US
  • The number of lots attempted that are released for distribution or for the next stage of manufacturing for the finished drug product or active pharmaceutical ingredient (API)
  • Annual Product Review (APR)/Product Quality Review (PQR) was performed within 30 days of the annual due date
  • The number of specification-related lots rejected for the drug referenced
  • The number of lots attempted pending disposition for more than 30 days on the last day of the time period within which the data being reported was collected.
  • The number of test results that fall outside the specifications or acceptance criteria for the drug
  • The number of lot release and stability tests conducted for the drug
  • The number of invalidated out of specification (OOS) results for finished drug product or API and stability tests due to laboratory error for the drug in terms of data validation

Standardizing the information is not believed to increase or ensure quality, but it will be easier to cross-compare companies and identify key elements that need to be addressed within a given company’s quality system.

For more information on this guidance click here.

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