Deviations and CAPA most frequent observations in FDA inspections

As seenin the  Warning Letter Report issued by the European Compliance Academy (ECA) observations in "Production Record Review" (21 CFR §211.192) are among the most frequent GMP deviations cited by the U.S. Food & Drug Administration (FDA). As in previous years, more Production Record Review deviations than others were again determined in 2009.
When taking a closer look at observations on 21 CFR §211.192 it becomes apparent that most complaints correspond to the handling of deviations and failure in CAPA. While in most cases the deviations were noted by the companies , they were not thoroughly investigated and no corrective and preventive actions were determined.

Some examples:

  • "Failure to thoroughly investigate any unexplained discrepancy or the failure of any batch to meet any of its specifications, whether or not the batch has already been distributed"
  • "Your firm has not thoroughly investigated the failure of a batch or any of its components to meet specifications. Your firm did not extended the investigation of a failure of a batch or any of its components to other drug products that may have been associated with the specific failure or discrepancy "
  • "Your response is inadequate because it does not include corrective actions regarding the violative product (which was incorrectly packaged and mislabeled) that may have been purchased by consumers. In your response, you also need to investigate other lots or products."

A comparable scenario also emerges with medical products, where Warning Letters on 21 CFR §820.100: "Corrective and preventive Action" always list the most observations.

Current developments as the Quality System Guide, ICH Q10 recently published by the FDA, the new draft for chapter 1 of the EC-GMP guideline and precisely these excerpts from the Warning Letters show the importance of correctly handling deviations and a respective CAPA system.

Wolfgang Schmitt
On behalf of ECA

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