Overview
Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.
Introduction
The pharmaceutical supply chain demands strict oversight to ensure the quality, integrity, and safety of products from the manufacturer to the end user. To support companies in achieving and maintaining regulatory compliance, COFEPRIS released a Self-Verification Guide specifically for warehouses engaged in the storage, distribution, or transportation of medicines, medical devices, hygiene products, and other regulated health supplies.
The guide is a practical tool for internal assessment, helping companies evaluate their own operations against current regulations and best practices.
COFEPRIS x Check Guide
COFEPRIS’s Self-Verification Guide is structured as a detailed checklist based on the NOM-059-SSA1-2015 standard, which outlines Good Storage and Distribution Practices in Mexico. It allows technical and operational staff to carry out an objective self-assessment, identifying gaps and improvement opportunities.
Key topics addressed in the guide include:
- Infrastructure and physical conditions: Evaluation of hygiene, organization, pest control, temperature and humidity controls, and facility security.
- Operational procedures: Assessment of Standard Operating Procedures (SOPs) for receiving, storing, shipping, and transportation.
- Personnel training: Verification of continuous staff training in topics such as storage practices and emergency response.
- Inventory control and traceability: Inspection of recordkeeping accuracy, batch tracking, expiration monitoring, and return procedures.
- Nonconformity management: Analysis of systems in place for identifying, documenting, and correcting deviations.
By using the guide, companies can proactively detect compliance risks and establish corrective actions before official inspections occur. COFEPRIS encourages regular use of the tool as part of continuous quality improvement.
Conclusion
The COFEPRIS Self-Verification Guide is a valuable step toward reinforcing Mexico’s health surveillance system, promoting a culture of compliance and encouraging accountability in companies that manage medicines and health-related supplies.
Beyond regulatory adherence, the guide helps improve the overall quality and reliability of services, fostering trust across the supply chain—from manufacturer to patient.
Organizations should adopt this guide as a core part of their internal quality processes, using it not only as a regulatory tool but as a strategic asset that enhances operational excellence and market reputation. Your voice can help shape a more efficient, modern, and harmonized regulatory environment in Brazil.
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References
Learn more about Mexico. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.Â