No Guidance Yet, But FDA Begins Clarifying Quality Metrics Program


The FDA will soon expect pharmaceutical manufacturers to collect certain data related to their quality systems under its burgeoning quality metrics program and submit those to the FDA for review. CMOs will be required to collect these data for their own facilities; whether they will need to provide those data to their clients or directly to the FDA is unclear.

While the agency has been tight-lipped about what exactly the quality metrics will entail, some FDA officials have begun discussing some of the data that the agency intends to collect.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Regulation (CDER) has frequently mentioned the idea of quality metrics and a quality scorecard during public remarks. The scorecard would include information illustrating whether a drug manufacturer is compliant with GMP requirements and that it is always on the lookout for potential problems. The idea would be to match known or potential issues to quality metrics, Woodcock has said.

The data provided are intended to give the agency information about how well the quality system is maintained at each facility, and how successfully it guards the quality of products made there.

This posting is taken from an article in the June 2015 issue of Bio/Pharmaceutical Outsourcing Report. The full article addresses FDA’s quality metrics and the full interview with Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Regulation (CDER). To learn more, click here.

Lisa serves as the Managing Editor at PharmSource. She holds a BS degree in journalism from Radford University, and has over 20 years of experience in editing, writing and managing newsletters and other print media, including B2B publications related to industries including science, pharmaceuticals, biologics and medical devices.

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