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 a clearer path for companies in terms of the regulatory review and inspection process/policies. FDA is having companies establish a risk-based approach to review and look at quality metric reporting. It is hoped that it will better be able to compare different company’s quality issues and have a more uniform assessment of manufacturing and product quality for all products.
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
It is not thought that standardizing the information will increase or ensure quality but it will be easier to cross compare companies and hopefully identify key elements that need to be addressed within a given company’s quality system.
For more information on this guidance click here.