Brazil GMP

ANVISA’s GMP Requirements in Brazil

Good Manufacturing Practices (GMP) are the foundation of pharmaceutical quality in Brazil. They are essential to ensure that medicines, APIs, cosmetics, medical products. Brazil’s ANVISA (National Health Surveillance Agency) mandates strict GMP compliance through regulations like RDC 658/2022, RDC 497/2021, and complementary guidelines.

  1. Who Needs to Comply?

    2. Any establishment involved in the manufacturing, repackaging, labeling, or importing of health-regulated products must follow GMP requirements. This includes:

    • Medicines: Governed by RDC 658/2022
    • APIs: Covered by RDC 654/2022
    • Cosmetics and Sanitizers: RDC 48/2013 and RDC 47/2013
    • Medical devices, including gases and radiopharmaceuticals
    GMP certification is granted per manufacturing site, and companies must comply regardless of whether the certificate is yet issued—non-compliance is a regulatory offense.
  1. Pharmaceutical Quality System Structure
    2. Per ANVISA’s adoption of the PE 009-14 (PIC/S guide), manufacturers must establish a Pharmaceutical Quality System aligned with ICH Q10, including:
    • Documented and monitored quality management system
    • Independent Quality Control department with technical authority and proper lab infrastructure
    • Risk management procedures across the product lifecycle
  1. Key GMP Requirements
      1. Facilities and Environment
        • Proper layout to prevent cross-contamination
        • Controlled clean areas with HVAC systems and physical separation
        • For sterile products: classified areas (grades A–D), pressure differentials, and microbiological monitoring
      1. Equipment
        • Installation, cleaning, and operation must be validated
        • Routine calibration and preventive maintenance are mandatory
      1. Materials and Supplier Control
        • Supplier qualification programs
        • Inspection and release testing upon material receipt
      1. Documentation and Procedures
        • Comprehensive and updated SOPs
        • Validation for processes, cleaning, and analytical methods
      1. Quality Control
        • Testing of raw materials and finished products
        • Independent and empowered QC department
      1. Recordkeeping
        • Batch records with full traceability and audit trails
        • Long-term secure storage of records
      1. Training
        • Programs for production, quality, maintenance teams
        • Ongoing effectiveness evaluations
      1. Deviation, CAPA, and Internal Audits
        • Structured systems for deviation investigation and correction
        • Scheduled internal audits with follow-up actions
      1. Inspections and Audits
        • ANVISA inspections (local or international) assess GMP implementation
        • The GMP Certificate is valid for 2 years
        • Renewals can be based on new inspections or via reliance on recognized foreign audits (e.g., MDSAP, FDA, PIC/S)
        • As of June 2024, ANVISA applies a reliance pathway (IN 292/2024) accepting certain foreign inspections
    1. ANVISA GMP Certification Process
      • File a certification request via ANVISA’s online portal
      • Review of recent inspection history (local or municipal)
      • Scheduling of inspection (by local authority or ANVISA)
      • Full inspection of manufacturing, lab, records, and quality systems
      • Technical report and publication of the GMP Certificate (valid 2 years)
      • Periodic renewal based on inspection or reliance audit evidence
    1. Common Compliance Challenges
      2. Incomplete or fragmented quality systems
      • Lack of environmental controls and validations for sterile areas
      • Poorly structured or outdated documentation
      • No independent or functional QC unit
      • Failure to maintain valid GMP certification
      • Unpreparedness for inspections or regulatory reliance
    1. Benefits of GMP Compliance
      • Regulatory credibility: mandatory for domestic sale and import
      • Product safety and consistency
      • Operational efficiency: reduced recalls, rework, or waste
      • Market competitiveness: enables exports and international certifications
      • Minimization of public health risks and legal liability

    How Masuu Can Help

    Masuu Pharma Quality and Regulatory Consultants offers complete technical and strategic support to help you achieve and maintain GMP compliance:

    • Technical Gap Analysis: We assess your current status and identify critical improvements
    • Quality System Implementation: Based on ICH Q10, including SOPs, training, risk management
    • Validations and Qualifications: Covering processes, cleaning, analytical methods, and equipment
    • Comprehensive Documentation: For calibrations, deviations/CAPA, and internal audits
    • Staff Training Programs: Tailored to key operational roles
    • Inspection Readiness: Conduct mock audits, train staff, and support live ANVISA inspections
    • GMP Certification Management: We guide petition submissions, manage reliance audits (e.g., MDSAP, FDA), and track certificate status
    • Ongoing Support: Post-certification audits and updates as new regulations emerge
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