Complaint Handling & Trending

Complaint handling is a GMP requirement under RDC 752/2022 and a core PMS activity. The complaint handling system must:

• Record all complaints received from any source;
• Investigate complaints to determine root cause;
• Classify complaints as adverse events or technical complaints (for NOTIVISA reporting);
• Implement corrective actions where appropriate; and
• Analyse complaint trends to identify systemic quality issues.

Trending analysis must be performed at least annually and documented in the PMS report.

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Official sources

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