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News about GMP/cGMP


FDA: Two Voluntary Programs on Quality Metrics

The US FDA initiated two new programs on a voluntary basis to gather industry feedback regarding the use of quality metrics. Namely these are a

  • Quality Metrics Feedback Program and a
  • Quality Metrics Site Visit Program.

The Feedback Program should encourage new drug application holders to request Type C Formal Meetings with the authority and to ANDA-holders to submit requests prior to an ANDA-meeting. The intention behind both requests is the same: to discuss quality metrics at an early stage.

The Quality Metrics Site Visit Program is designed to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program.

The FDA says that “The participation in either of these efforts is voluntary and the programs are intended to foster the joint efforts of FDA and stakeholders to further develop an FDA Quality Metrics Program. The FDA Quality Metrics Program aims to evaluate a new approach for regulatory oversight of pharmaceutical products through the collection of certain quality information developed and maintained in the course of manufacturing drugs under current good manufacturing practices."

FDA intends to use quality metrics data to further develop the Agency's risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments).


FDA: Quality Metrics

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