FDA publishes Technical Guide on Quality Metrics

The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn’t been finalised yet. Read more about the Technical Quality Metrics Guide.

see http://www.gmp-compliance.org/enews_05437_FDA-publishes-Technical-Guide-on-Quality-Metrics_15515,S-QSB_n.html

The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn’t been finalised yet.

The so-called FDA Quality Metrics Technical Conformance Guide should supplement the Guidance for Industry: Request for Quality Metrics published on 28 July 2015 which is currently still in the draft version. We have recently published a GMP News about a Quality Metrics Case Study at Aenovaregarding a possible implementation. Now, the Technical Guide defines how the industry should submit Quality Metrics to the…