ANVISA’s New Resolution on Good Storage Practices (GAP)

The National Health Surveillance Agency (ANVISA) has reaffirmed its Good Storage Practices (GAP) and Certification of Good Storage Practices for goods under health surveillance, including sanitizers in bonded warehouses. The resolution, effective from 03-Mar-2025, mandates that sanitizer storage must adhere to these practices, focusing on:

  • Storage Control: Ensuring proper handling during storage, clearance, and inspection by authorized agencies.
  • Quality Management System (QMS): Bonded warehouses are required to implement a QMS that defines and reviews storage processes, trains operators, and ensures adherence to procedures.
  • Environmental Controls: Storage areas must be equipped with instruments to monitor temperature and humidity, protect products from environmental factors, and restrict access to authorized personnel only.

This resolution aims to ensure the consistent quality and safety of health-related products stored in bonded warehouses.

Region: Brazil

Source: https://antigo.anvisa.gov.br/documents/10181/6764059/RDC_938_2024_.pdf/79429825-81d7-4d05-94b5-66ffe64ea6c3

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