OOS, Complaints also need CAPA Plans

Recommendation

13/14 June 2023
Vienna, Austria

GMP and Quality Requirements for Radiopharmaceuticals

Some companies still might thing that only deviations lead to corrective and preventive actions (CAPA). But that is not true. A recent Warning Letter issued by the FDA is picking this up now. An Indian pharmaceutical company manufacturing sterile injectables and solid dosage drug products did conduct out-of-specification (OOS) and complaint investigations which were not adequate, according to FDA. This was "including the identification of the root cause and timely implementation of effective corrective action and preventive action (CAPA) plans".

The FDA thought that some OOS investigations did not provide sufficient scientific justification to define the root cause. And - of course - there was criticism that as a CAPA, staff was simply retrained to avoid recurrence. Here, however, actions based on a precisely defined root cause were expected. The investigations were not detailed enough; the determination of the effectiveness of the CAPAs was unclear. Similar problems arose in the processing of complaints.

Therefore, before an organisation defines corrective and preventive actions, it is important to carry out a systematic investigation process throughout the entire chain of events to determine the true cause.

Please also see the FDA's Warning Letter to Shilpa Medicare Limited for further details.