Corrective and Preventive Action (CAPA)

The Corrective and Preventive Action system assures the tracking and trending of issues requiring mid-term and long-term corrective actions. This procedure will provide guidance on the requirements and use of the system as well as the procedure for processing CAPAs.



The CAPA system will be used to track and trend corrective and preventative actions planned to address known issues or to implement quality improvements. These requirements apply to all GMP operations and areas. This may include, but is not limited to:

  1. Deviation / non-conformance
  2. Product Complaints
  3. External and internal audit observations
  4. Annual Product Reviews
  5. Regulatory Issues
  6. Any issues that require mid-term and long-term corrective or preventative action, with formal tracking and documentation
  7. Recommendations of executed validations

CAPA - Corrective and Preventive Action