Managing Deviations and CAPA still in the focus of the Inspectorates

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Recently, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published some very interesting and comprehensive information in their MHRA GMP Inspection Deficiency Data Trend 2016, covering 324 GMP inspections performed in 2016. According to the report, deficiencies relating to 'Quality Systems' are by far the most prevalent observed during inspections.

As in the previous years, appropriate handling of deviations, investigations and CAPA again causes a lot of concerns. Taking a closer look at the examples of the findings it becomes obvious that root cause analysis, impact assessment and associated actions are still challenging for many companies:

  • Deviations were not fully recorded and investigated
  • Deviation investigations did not include an appropriate level of investigation and did not capture all relevant information
  • Significant lack of detail in investigations
  • Root cause was not always adequately considered
  • Appropriate CAPAs were not implemented
  • The quality impact of the deviation and CAPAs implemented were not appropriately assessed
  • Appropriate measures may not have been taken to prevent reoccurrence
  • No recorded measures to consider prevention
  • No process for assessing the effectiveness of CAPA in line with Quality Risk Management principles

And what about the FDA? In a recent Warning Letter to Porton Biopharma in the U.K. from January 19, 2017, the US Food and Drug Administration (FDA) cited the company for failing to "thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications" and they directly refer to corrective action and preventive actions:

  • "The only correction implemented at that time was to update your standard operating procedure"
  • "Your firm's corrective action and preventive action (CAPA) plan was inadequate"
  • "We encourage you to consider additional CAPA to mitigate risk"
  • "Your firm has failed to implement prompt and sufficient corrective and preventive actions"

On January 18th, the FDA sent a Warning Letter to the Indian API manufacturer CTX Life Sciences, with the conclusion that the company failed to "ensure all production deviations are reported and evaluated, and that critical deviations are investigated and conclusions are recorded" and that batch disposition was made before "adequate investigations into these significant deviations" were conducted.

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