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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 formally documented in the quality system with completion dates, verification evidence, and approval by the Responsável Técnico, and must be made available to ANVISA inspectors upon request. When ANVISA inspection findings result in non-conformity notices (in an auto de infração or inspection report), the company must address them through the CAPA process and submit evidence of closure to ANVISA.

Official sources

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