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Corrective & Preventive Action (CAPA)

The CAPA (Corrective and Preventive Action) process is a critical GMP requirement under RDC 752/2022. It is the primary mechanism for addressing non-conformities and preventing their recurrence.

Corrective action addresses an existing non-conformity or adverse event — identifying root cause and eliminating it.

Preventive action addresses potential non-conformities before they occur — identifying potential causes and eliminating them.

The CAPA process must include:

  1. Identification of the problem or potential problem;
  2. Root cause analysis;
  3. Definition of corrective/preventive measures;
  4. Implementation of measures;
  5. Verification that measures were effective; and
  6. Communication to management.

All CAPAs must be documented in the quality system and available to ANVISA inspectors. ANVISA inspection findings that result in non-conformity notices must be addressed through the CAPA process.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.