The RDC 938/2024 resolution, published by Anvisa, introduces significant updates to the Good Storage Practices (GSP) for goods and products subject to health surveillance in bonded warehouses. Effective from March 3, 2025, this regulation replaces RDC 346/2002, aiming to enhance safety, quality, and efficiency in the country’s logistics operations.
Below, we explore the resolution’s key points, its impacts on the industry, and the necessary steps for compliance.
What Does RDC 938/2024 Establish?
RDC 938/2024 sets out clear and comprehensive guidelines for the storage of goods and products under health surveillance. It addresses aspects such as Quality Management System (QMS) implementation, infrastructure requirements, documentation, and training.
Scope:
- Companies handling goods subject to health surveillance in bonded warehouses, including express and postal shipments.
- Excludes duty-free shops, special warehouses, and facilities exclusively dealing with bulk food or vegetable oil shipments.
Objectives:
- Ensure the quality and safety of stored products.
- Mitigate sanitary and operational risks.
- Standardize processes in line with international best practices.
Key Requirements of RDC 938/2024
The resolution introduces significant changes that will require operational adjustments from companies. Below are the highlights:
1. Quality Management System (QMS)
Companies must implement a robust QMS to monitor all stages of the storage process. This system should include:
- Documented procedures for control and deviation prevention.
- Regular audits and self-inspections.
- Risk analysis integrated into processes.
2. Infrastructure and Facilities
Warehouses must meet the following specifications:
- Separate areas for receiving, shipping, and storage.
- Dedicated spaces for products under special control, quarantine, and inspections.
- Strict temperature and humidity control with continuous monitoring and thermal mapping.
- Periodic calibration and qualification of equipment.
3. Temperature-Sensitive Products
Products sensitive to temperature require special attention. The resolution demands:
- Continuous monitoring of storage conditions.
- Backup energy sources to prevent failures.
- Detailed records of ambient exposure time during operations.
4. Qualification and Validation
All equipment and computerized systems impacting quality must be qualified or validated. This includes:
- Thermal qualification of areas and equipment.
- Validation protocols based on national or international standards.
5. Documentation and Records
The resolution emphasizes strong document management practices:
- All documents and records must be updated, traceable, and securely stored.
- Temperature and humidity records must be maintained for at least two years.
Impacts on Companies
Compliance with RDC 938/2024 requires a comprehensive review of operations and investments in infrastructure, technology, and training. Key challenges and opportunities include:
- Team Training: Invest in periodic training to ensure understanding and application of Good Practices.
- Facility Adaptation: Update spaces and equipment to meet the new requirements.
- Process Automation: Implement computerized systems for monitoring and control.
- Maintaining Competitiveness: Compliant companies are likely to stand out, earning trust from clients and partners.
Deadlines and Penalties
Anvisa has set specific deadlines for company compliance:
- September 1, 2025: Completion of thermal mappings.
- March 2, 2026: Completion of performance qualifications and system validations.
Non-compliance may result in:
- Sanitary infractions under Law 6.437/1977.
- Preventive suspension of activities by Anvisa.
How to Prepare?
To ensure compliance with RDC 938/2024, companies should:
- Conduct internal audits to identify process gaps.
- Update QMS, focusing on monitoring and risk prevention.
- Invest in technologies to automate monitoring and documentation.
- Consult regulatory experts to guide necessary adjustments.
Conclusion
RDC 938/2024 represents a significant advancement in the safety and efficiency of Brazil’s logistics sector. While the requirements are demanding, they also present opportunities for companies to enhance their operations and stand out in the market.
Adopting Good Storage Practices is not just about compliance—it’s about competitiveness and a commitment to quality.
📝 Access the translated version of RDC 938/22
The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.
Click the link to access the Original Version
For any questions, contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
