Anvisa updates quality control rules for Brazilian laboratories

Anvisa has issued a new resolution redefining the rules for public and private laboratories responsible for quality control testing of products and services subject to sanitary surveillance in Brazil.

Key requirements include maintaining a valid sanitary license, employing a qualified technical manager, and adopting a quality management system aligned with the international ABNT NBR ISO/IEC 17025 standard. The new rules also expand biosafety requirements, such as risk assessments, pest control programs, waste management, and regular staff training for handling physical, chemical, and biological agents.

Laboratories testing medicines and vaccines must also follow World Health Organization (WHO) best practices for pharmaceutical quality control. Under the new regulation, laboratories are required to share data with Anvisa for product monitoring purposes. Facilities have one year to adapt to these new standards.