Culture and Process Capability Continue In Focus as FDA Releases Its Draft Quality Metrics Guidance

FDA is asking for industry input on how quality culture and process capability evaluations can contribute to the “baseline” metrics it has put on the table for review in its draft quality metrics guidance.

Released in late July, the draft guidance and the accompanying Federal Register announcement point to the importance of quality culture and process capability in advancing drug quality and its regulation and invite industry to join with the agency in probing further into the role the two issues can play in conjunction with its metrics initiative. [Links to the draft guidance and Federal Register notice are provided below.]

The guidance and announcement provide a detailed explanation of the development of the metrics initiative and its purpose in helping the agency refine its risk-based compliance and inspection policies, reduce drug shortages, and encourage better quality management systems and manufacturing innovation.

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