Understanding GLP Archives: Establishment, Control, Compliance and Future Perspectives

Archives are crucial for regulatory compliance with Good laboratory practice. They ensure the quality, integrity, retrieval of documents, specimens and their support records generated during non-clinical health and environmental safety studies. An effective archival system facilitates the regulatory compliance and allows for the reconstruction of GLP studies. Although the archival management is the responsibility of Test facility management, it requires provide adequate space, authorized access and environmental controls, disaster recovery plans, preventive control measures and assigned responsibilities. The archival systems face significant challenges due to the increasing transition from documents (paper based) to hybrid/digital archives, including data integrity, cybersecurity, and data recovery concerns. This review summarizes operational and regulatory aspects of Good Laboratory Practice compliant archive management with emphasis on archive organization, environmental controls, electronic records, retrieval procedures, and risk-based quality assurance. This review aims to provide a comprehensive understanding of GLP-compliant archival systems based on OECD guidance document No. 15, and to support test facilities in establishing and maintaining effective archive systems in compliance with regulatory requirements.