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Internal Audit Requirements

RDC 752/2022 requires manufacturers to conduct internal audits at planned intervals to determine whether the quality management system conforms to planned arrangements and to RDC 752/2022 requirements, and whether the QMS is effectively implemented and maintained.

Key requirements:

  • Audit programme covering all aspects of the QMS, at frequencies based on area importance and previous results;
  • Auditors must be independent of the areas being audited;
  • Audit results must be documented in audit reports;
  • Non-conformities found must be corrected and root causes eliminated (CAPA);
  • Management must be informed of audit results; and
  • Records of all audits must be maintained.

The internal audit programme must be available to ANVISA inspectors during GMP inspections.

Official sources

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