GCP-/GVP inspections – Corrective and preventive action (CAPA) plans

On receiving the inspection report, the addressee is given four weeks in which to propose measures to address the findings of the inspection.

This document, called a corrective and preventive action, or CAPA, plan, must distinguish corrective action (action intended to resolve shortcomings identified during the inspection) from preventive action (action intended to prevent a recurrence of shortcomings identified during the inspection).

Furthermore, it must be apparent that the proposed preventive action is intended to address the root cause of the shortcoming in question. 

Requirements applicable to CAPA plans

  • CAPA plans must be paginated, dated, version-numbered and signed by the addressee;
  • They must be based on a root-cause analysis;
  • Corrective and prevention action must both be described. If no corrective and/or preventive action is proposed for a finding, the reasons for not doing so must be stated.
  • A completion date and the name and job title of the person responsible must be given for each individual action.


Last modification 07.11.2018

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