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Q&A with Peter Smith and David Elder, Strategic Compliance Consulting, PAREXEL International, on acceptable deviation investigations. Smith and Elder are both former senior officials with FDA.
Q. What are FDA expectations for an acceptable deviation investigation?
A. Deviations happen. FDA recognizes this and requires deviations to be investigated and documented. Thorough and timely deviation investigations are critically important. Typically, deviation investigations should be led by the Quality Unit and conducted in collaboration with the operational department or laboratory. This collaborative approach provides for both objectivity and subject-matter expertise. Clearly, the resulting material disposition decision must be objective and fully supportable. Further, FDA expects corrective and preventive action (CAPA) to be initiated when a trend, or even a single deviation investigation, identifies opportunities to revise and improve operations and/or procedures to prevent such deviations in the future.
A thorough deviation investigation should be completed in a timely manner (typically within 30 days) and contain the following elements:
During FDA inspections, deviation investigations are among the most common areas covered. The investigation report must be designed for the reader, providing information and evidence that fully support the findings, conclusions, and actions. In short, the report should relate a story that can be clearly understood by a third party months or even years after the event and the investigation.
FDA investigators will typically record any failure to conduct a thorough and timely deviation investigation on the FDA-483 issued at the conclusion of the inspection. If, however, FDA documents a pattern of failures to conduct thorough and timely investigations, the inspection is likely to be classified as Official Action Indicated, with the appropriate compliance options pursued.
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