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ANVISA 2026-01-28

GMP and CBPF: how to get Brazil's Good Manufacturing Practices Certificate

GMP is not a rule, it is a system. Whoever manufactures ANVISA-regulated products in Brazil must operate within it, and the CBPF is the formal evidence.

What is GMP

Good Manufacturing Practices (GMP) is the set of procedures, controls and infrastructure that ensures each batch manufactured has reproducible quality and verified safety.

What is CBPF

The Certificate of Good Manufacturing Practices (CBPF) is the document issued by ANVISA after on-site inspection. Typical validity: 2 years.

How the inspection works

  1. Formal request via SOLICITA
  2. Payment of corresponding TFVS fee
  3. Scheduling of on-site inspection
  4. Technical visit of 1 to 3 days
  5. Inspection report with corrections deadline
  6. CBPF issuance after verifying corrections

GMP pillars

  • Qualified personnel with documented training
  • Facilities designed to prevent cross-contamination
  • Qualified and calibrated equipment
  • Complete versioned documentation (SOPs, records)
  • Quality control with own or contracted lab
  • Formalized change management
  • CAPA: corrective and preventive actions
  • Annual internal audit

For international manufacturers

If you already comply with FDA cGMP, EU GMP, PIC/S or ISO 13485, you have most of the foundation. ANVISA recognizes equivalences in some cases.

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