CAPA among the most frequent GMP Deviations cited in FDA Warning Letters

As indicated in the GMP News on the ECA's Warning Letter Report, Production Record Review deviations are (again) the most frequent GMP observation made by the FDA. In the previous periods, observations regarding this subject were always No.1 or No.2 in the ranking of cited GMP deficiencies. 

After a closer look at these citations, it becomes obvious that most observations are caused by failures in deviation management and CAPA. In most cases, deviations were noticed by the pharmaceutical company but no sound investigation was performed and no consequences were defined.

Examples are:

  • "Your firm failed to perform an investigation or determine the root cause…"
  • "No corrective or preventive action was documented"
  • "We are unable to evaluate these corrective actions because you failed to provide supporting documentation"
  • "You failed to conduct adequate investigations that result in your implementation of corrective actions to prevent recurrence of the problems and evaluate other potentially affected lots"
  • "Although a deviation investigation was conducted, the investigation was not thorough (e.g., identification of other affected lots, root cause determination, and corrective and preventive actions)"

Current developments like FDA's published Quality System Guide, ICH Q10 and those Warning Letter citations clearly emphasise the increasing relevance of a proper deviation management and CAPA.

Wolfgang Schmitt
CONCEPT HEDEILBERG (a service provider entrusted by the ECA Foundation)

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