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FDA: Revision 1 of Quality Metrics Guidance

On 23 November 2016, the US Food and Drug Administration (FDA) released a Revision 1 of the draft guidance to Quality Metrics which was initially published in July 2015. The revision with the new title “Submission of Quality Metrics Data” came on short notice and is open for comments and suggestions until 24 January 2017.


What has changed?

The revised draft guidance describes FDA’s plans for an initial, voluntary phase of a quality metrics reporting program. FDA expects that this will allow the Agency to learn more about a limited set of quality metrics and associated analytics, and will help any future FDA decision-making about its quality metrics program. This second draft also provides an opportunity to gain additional perspectives from industry participants on the future use of quality metrics data. The beginning of this program is scheduled for early 2018.

After evaluating the results of the voluntary phase of the quality metrics program in 2018, FDA intends to develop a mandatory quality metrics reporting program.

In the revised draft guidance, FDA has reduced the number of metrics from four primary metrics and three optional metrics to three primary metric areas:

  • lot acceptance rate
  • invalidated out-of-specification rate
  • product quality complaint rate.

FDA continues to recognize the importance of measuring an establishment’s pharmaceutical quality system robustness and quality culture (e.g., senior management engagement, Corrective Action and Preventive Action effectiveness and continual improvement, and process capability/ performance).

Furthermore, the guidance was revised to

  • clarify the technical definitions and provide illustrative examples for specific scenarios (see Appendix B, examples)
  • contemplate submission of either product reports segmented by site or site reports segmented by product which should be publicly recognized in a quality metrics reporters list
  • allow the publishing of a quality metrics reporters list
  • address the special complexities for grouping non-application drugs products
  • define product families for finished drug products and APIs to group similar products with similar manufacturing operations
  • put into perspective special considerations regarding product quality complaints for OTC products
A Technical Specifications Document entitled ‘‘Quality Metrics Technical Conformance Guide, Version 1.0’’ was published on June 27, 2016.This guide provides technical recommendations for the submission of quality metrics data. FDA intends to publish Version 2.0 of the Technical Conformance Guide soon.
FDA anticipates that an electronic submission platform will be available to test in 2017. From January 2018 on the electronic portal should be open for voluntary submissions of data.

FDA: Quality Metrics Guidance, Revision 1
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