Quality Metrics Data Guidance Out

FDA has published a draft guidance, Submission of Quality Metrics Data, explaining and implementing the voluntary reporting phase of its new quality metrics reporting program. The document says that CBER and CDER will use submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement in drug manufacturing.

In the voluntary reporting phase, the guidance says, FDA expects to learn more about a limited set of quality metrics and associated analytics, and how to improve the quality metrics reporting program. The agency will accept voluntary data submissions from owners and operators of human drug establishments. It says it expects that the large majority of voluntary reports will come from establishments engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms of “covered drug products” or active pharmaceutical ingredients used in the manufacture of “covered drug products.”