CAPAs are one of the most important elements of the pharmaceutical Quality System.  During Day 1 of the PDA/FDA Joint Regulatory Meeting, Jonathan Chapman, Senior Policy Advisor at the FDA, spoke about CAPAs.

Traditionally, we think of CAPAs as follows:

  • Corrective actions are actions implemented to correct an identified problem.
  • Preventive actions are actions implemented to prevent recurrence of problems.

What companies sometimes forget is that preventive actions are also proactive in that they are put in place to prevent occurrence of the problem.  This goes one step further in the process by broadening a CAPA to similar processes, equipment, tests, products, facilities, etc. to see whether the original problem might apply to these expanded areas.

There are many 483s and Warning Letters (WLs) in which the FDA cited that the “CAPA wasn’t broad enough to prevent recurrence or occurrence of the problem.”

Additionally, a proper root-cause analysis where the true root cause is determined is crucial for establishing proper, well-designed CAPAs.  You can’t fix what you don’t know.  A frequent citation in 483s and WLs is that the investigation did not establish a true root cause and, therefore, the CAPAs are ineffective.  Lachman does many retrospective investigation reviews and our main finding is that the root cause was not determined.  The second main finding is that CAPAs are inadequate to prevent recurrence or occurrence of the problem.  In busy facilities with a lot of investigations, the tendency is to stop at “a root cause” instead of digging for “the root cause,” leading to ineffective CAPAs, which can be seen with repeat deviations.

CAPA effectiveness is another area of concern for the FDA and an area where Lachman sees deficiency as well.  A CAPA that is truly a corrective or preventive action should have a CAPA effectiveness check.  CAPA effectiveness checks need to be detailed enough to evaluate effectiveness, but not so narrow that they don’t show issues.

Struggling with your CAPA system?  CAPAs not preventing problems?  Have a concern about a specific CAPA?  Lachman can help!  Reach out to us at LCS@LachmanConsultants.com for a consultation.