Do your OOS Investigations include root cause evaluation and follow-up?

According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated.  A written record of the investigation shall be made and shall include the root cause evaluation, conclusions and follow-up.

root cause evaluation - oos investigation

A company recently received the following observation:

….. Written records of investigations into unexplained discrepancies and failures of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

Your investigations are inadequate for reasons including but not necessarily limited to root cause evaluation, corrective and preventative actions and the performance of an investigation.

Specifically, you discovered an Out-of-Specification result for …, lot … for particulate matter. The particles were determined to be … Results of personnel interviews reported worn seals of the pump which had never been replaced. You identify corrective and preventive actions including but not limited to replacement of the seals on this pump and other similar pumps, however, you did not provide documentation supporting you performed these actions. Furthermore, you failed to document any review of previous activities to scientific support the isolation of this event.

According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to laboratory investigations (21 CFR 211.192) have been in the top 10 observations cited by the FDA each year.

For more information on conducting an Out of Specification (OOS) investigation, refer to the FDA’s newly update Guidance Document, Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Issued May 2022 and our June 16th blog post Are you prepared for an OOS Investigation?

To view more observations pertaining to laboratory investigations, refer to the following GMP Trends® Issues: 1075, 1079, 1084 and 1089

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