FDA plans a new approach to facility inspections

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The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg (FDA’s Deputy Commissioner for Global Regulatory Operations and Policy) and Cynthia Schedar (Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research) discuss ideas to improve the quality of inspections.

The two high level agency representatives discuss a new approach to facility inspections, "one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance. To put it simply: the inspections can yield also carrots, and not just sticks."

The new approach will consider the findings by using them to plan the frequency of FDA Inspections. In addition, a good overall quality management system and culture might even lead to more flexibility for post-approval manufacturing changes. This was also a goal of ICH Q10 but regulators did not implement this idea yet. The new FDA proposal could be a starting point for providing regulatory flexibility to those companies who do more than what is needed.

FDA is currently preparing a questionnaire to standardize inspections with the goal of "uniformly harvesting the kind of data that supports accurate measures of quality." The authors go on by saying "We believe that by improving the inspection process in this way, future “metrics” that define quality will be understood and aspired to by manufacturers — no matter where they are in the world."

The new inspection approach might complement the current initiative to develop a FDA Guideline on Quality Metrics which is an intensively discussed initiative. Also other regulators around the world might consider this idea. Just recently the MHRA has published an update on their risk based inspection model. According to the MHRA approach to inspections questionnaires will be used to define the frequency as well. But the MHRA intends also to use the questionnaire once between inspection cycles to define the frequency.