FDA issues draft guidance on quality manufacturing metrics

FDA's Janet Woodcock

After years of dealing with avoidable manufacturing issues that led to questionable meds and drug shortages, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), initiated the Office of Pharmaceutical Quality last January. The idea is for it to work up guidelines that will push even reluctant drugmakers toward quality manufacturing and establish a risk-based method for setting inspections. The office is now providing an idea of how that will work.

This week, the FDA issued draft guidance in a document titled "Request for Quality Metrics Guidance for Industry." It was issued only for comment ahead of a meeting scheduled for Aug. 24, in which the agency will solicit feedback.The office will establish benchmarks that will allow the FDA to better understand which plants need to be more closely monitored. The quantitative information will replace the more general ideas the agency has had about the state of manufacturing quality and allow the FDA to track processes through a product's life cycle.

As Regulatory Focus points out, the FDA plans to ask drugmakers to provide 10 baseline quality metrics, things they are already collecting such as the number of lots attempted and how many of those were rejected for specification-related issues during or after manufacturing. It will seek out-of-spec results, including in stability testing, and wants to know about customer complaints--all things that the FDA is already looking at during inspections--which can lead to warning letters. But by seeking this info on an ongoing basis, the FDA hopes to avoid problems getting to that level.

The agency also will ask for 5 optional metrics, Regulatory Focus reports, that gauge the involvement of manufacturing management, things like whether the head of quality management reviewed all annual product reviews or product quality reviews.

The upside for drugmakers is that if they consistently have quality processes, the frequency that they get inspected could fall. Those with issues, or who refuse to provide the data, will go to the top of the inspection list.

The proposed guidance comes as the agency also has stepped up its manufacturing oversight internationally, particularly in India and China, two countries that supply many of the generic drugs and ingredients used in U.S. pharmaceuticals and two where a noticeable number of producers have had repeated issues with quality. As Woodcock said when laying out her plan, the agency hopes to create a "culture of quality," that can reduce the number of plant closures and recalled drugs and to better protect consumers.

- here's the draft guidance
- here's the Regulatory Focus report

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