ANVISA risk-based inspection: What You Need to Know

Key Takeaways

• Regulation effective: ANVISA RDC 982/2025 took effect July 28, 2025, establishing risk-based criteria for Good Manufacturing Practices (CBPF) and Good Distribution Practices (CBPDA) certification.
• Four risk factors: Inspections now prioritize based on product risk class, establishment complexity, compliance history, and valid reports—enabling targeted regulatory resource allocation.
• Broad scope: The framework covers APIs, medicinal products, biologicals, medical devices, and cannabis products for medicinal purposes manufactured or distributed in Brazil. Clinical trial regulations are evolving alongside these changes.
• Compliance incentive: Facilities with strong compliance records may qualify for reduced inspection frequency, while violators face enhanced oversight.

What Changed with RDC 982/2025?

ANVISA—the Agência Nacional de Vigilância Sanitária—overhauled Brazil's pharmaceutical inspection framework through Collegiate Board Resolution No. 982, published July 28, 2025. The resolution replaces the previous uniform inspection schedule with a dynamic, risk-based approach.

Under the old system, ANVISA inspected pharmaceutical establishments on fixed timelines regardless of their risk profiles or compliance history. The new model groups establishments using objective risk parameters. This lets ANVISA focus resources on higher-risk operations while allowing compliant, lower-risk manufacturers to operate with proportional oversight. Broader regulatory trends across Latin America show similar shifts.

The program applies to both the Certificado de Boas Práticas de Fabricação (CBPF) for manufacturing and the Certificado de Boas Práticas de Distribuição e/ou Armazenagem (CBPDA) for distribution activities. Related coverage examines how this shift affects multinational pharmaceutical operations.

How Does ANVISA Classify Risk?

ANVISA evaluates four primary criteria to determine inspection priority and frequency. These factors collectively shape the regulatory intensity each facility faces.

Product Risk Class: ANVISA categorizes products by inherent risk linked to therapeutic use, formulation complexity, and patient population vulnerability. Critical care products and therapies for vulnerable populations attract greater scrutiny. This ensures inspection resources target products with the highest potential impact on patient safety.

Establishment Complexity: Regulators assess operational scope including product line count, manufacturing process variety, storage conditions, and distribution network scale. Facilities with multiple product categories or advanced manufacturing technologies face more stringent inspection schedules than simpler operations.

Compliance History: Establishments with documented violations or prior deficiencies receive heightened oversight. Those maintaining strong compliance records may qualify for reduced inspection frequency. This structure rewards effective quality systems and encourages continuous improvement.

Valid Reports: ANVISA incorporates data from inspection reports, adverse event notifications, and complaint investigations into risk scoring. Facilities with quality issue histories receive priority placement in inspection queues.

Impact on GMP Compliance Requirements

The RDC 982/2025 rollout changes compliance requirements for pharmaceutical manufacturers in Brazil. The framework creates a differentiated environment where compliance performance directly shapes inspection intensity.

High-risk product manufacturers and complex facilities should expect more frequent inspections targeting critical process controls, data integrity systems, and product quality assurance. Conversely, facilities with strong compliance records and lower-risk portfolios may face lighter inspection burdens.

This shift incentivizes companies to align quality assurance and internal audit programs with ANVISA's risk criteria. Manufacturers must develop compliance strategies addressing product-specific risks, establishing strong process controls, and maintaining transparent quality metrics documentation.

Companies operating in Brazil must re-evaluate quality management systems—particularly deviation management, corrective and preventive action (CAPA) protocols, and management review processes. Internal risk assessments should mirror ANVISA's four criteria to identify gaps and prioritize remediation.

Why Data Integrity Matters

Data integrity sits at the core of ANVISA's risk-based inspection protocol. Global regulators have intensified data integrity scrutiny following quality failures linked to record manipulation. ANVISA embeds data integrity assessments directly into inspection procedures because reliable data underpins all GMP and GDP compliance determinations.

Investigators examine manufacturing records, laboratory data, batch documentation, and distribution records. Common deficiencies include incomplete audit trails, unexplained data modifications, weak electronic system controls, and insufficient staff training.

Manufacturers must build data integrity programs spanning electronic record systems, paper documentation, laboratory information management systems (LIMS), and enterprise resource planning (ERP) platforms. Key elements include clear data governance policies, access controls with comprehensive audit trails, regular data integrity audits, and targeted training for staff handling data.

Strategic Preparation for Manufacturers

RDC 982/2025 requires strategic adjustments for companies with Brazilian operations. Industry stakeholders should address several priority areas.

Align Compliance Programs: Quality management systems and internal audit protocols should reflect ANVISA's risk-based criteria. Companies must conduct thorough risk assessments of product portfolios and manufacturing operations to anticipate inspection focus areas.

Enhance Quality Assurance: Internal audit functions should adopt risk-stratified schedules allocating resources to higher-risk products, complex processes, and areas with documented compliance issues rather than conducting uniform facility audits.

Use Compliance History: Facilities with strong records should document performance metrics and communicate these to ANVISA. Transparent quality reporting, proactive deviation disclosure, and effective corrective actions can support requests for proportionate inspection schedules.

Prepare High-Risk Operations: Companies producing high-risk products or managing complex facilities should strengthen process controls, improve documentation systems, and implement comprehensive data integrity measures. Early engagement with ANVISA may clarify expectations and reduce inspection findings.

Regional and Future Implications

ANVISA's risk-based inspection program reflects broader Latin American regulatory modernization. Implementation experiences may influence neighboring countries and contribute to regional harmonization discussions.

The model should improve pharmaceutical quality and patient safety in Brazil by directing regulatory attention to highest-risk areas. As the program matures, ANVISA may extend risk-based approaches to product approvals, post-market surveillance, and pharmacovigilance.

International companies with Brazilian interests must monitor ANVISA guidance, inspection patterns, and compliance expectations. Prepare for potential expansion of data integrity requirements, increased contract manufacturing scrutiny, and greater supply chain transparency demands. Additional analysis tracks these regulatory developments.

Frequently Asked Questions

Primary Sources

1. Agência Nacional de Vigilância Sanitária (ANVISA). Collegiate Board Resolution (RDC) No. 982, July 28, 2025. Establishes health risk management criteria and compliance monitoring for GMP/CBPF and GDP/CBPDA certification.