Brazil’s ANVISA Sets High Bar for Pharmaceutical Manufacturers with Compliance Audit Checklist
New Compliance Requirements for Pharmaceutical Companies Operating in Brazil
In an effort to ensure the highest standards of quality and safety in pharmaceutical manufacturing, Brazil’s National Health Surveillance Agency (ANVISA) has implemented a comprehensive compliance audit checklist. This new requirement aims to strengthen ANVISA’s regular inspection systems and guarantee that all pharmaceutical manufacturers operating in the country meet stringent international good manufacturing practices (GMP) guidelines.
Pre-Inspection Requirements
To prepare for their license renewal, pharmaceutical companies are required to submit detailed information about their products and facilities at least six months prior to their scheduled audit. This includes:
- Geographical coordinates of the facility
- Records of previous inspections by other healthcare agencies
ANVISA’s risk-based approach means that certification renewals will be subject to a thorough assessment, with inspectors deciding whether an on-site inspection is necessary based on the level of risk associated with each facility.
Key Areas of Focus During Audit Inspections
When ANVISA inspectors arrive at a facility for an audit, they will be looking for strict adherence to GMP guidelines in the following areas:
- HVAC systems and water treatment systems: Ensuring that these critical systems are properly maintained and functioning correctly.
- Quality systems: Verifying that quality control procedures are clearly defined and consistently applied across all operations.
- Validation guidelines and procedures: Checking that senior management is involved in the approval of SOPs, manufacturing documents, and other critical documents.
- Specifications and analytical methods: Ensuring that product specifications and analytical methods meet international standards.
- Hygiene conditions: Verifying that facilities are maintained in a clean and hygienic state to prevent contamination.
- Employee training: Checking that employees are adequately trained in production, quality control, and quality assurance procedures.
The Audit Process
ANVISA inspectors are known for their tough and strict approach, often conducting multi-product inspections and speaking fluent English. While no report will be issued at the end of an inspection, a comprehensive report must be generated within 30 days. A successful audit will result in the issuance of a GMP certificate, which is essential for pharmaceutical manufacturers operating in Brazil.
Conclusion
With ANVISA’s compliance audit checklist setting the bar high, companies must prioritize quality and safety to meet the agency’s rigorous standards. By adhering to these guidelines and maintaining transparency throughout their operations, pharmaceutical manufacturers can ensure that they remain compliant with Brazilian regulations and continue to operate safely and effectively in the country.