Archiving is the systematic storage and preservation of GLP study records, raw data, and final reports to ensure their integrity, accessibility, and protection for the required retention period. The OECD GLP Principles mandate that each test facility have designated archive facilities with controlled access and environmental conditions appropriate for the types of records stored. Proper archiving ensures that study data can be reconstructed and audited years after study completion.
Archive Facilities
Archive facilities must be designed to protect records from damage due to fire, water, pests, and environmental degradation. Access must be restricted to authorized personnel, with a log maintained of all entries and withdrawals. Separate archive areas may be needed for different record types, such as paper documents, electronic media, and biological specimens.
Records to Be Archived
All documentation necessary for the reconstruction of a GLP study must be archived, including the study plan, raw data, final report, QAU records, Standard Operating Procedures (SOPs) , equipment calibration and maintenance records, and personnel training files. For in vivo studies, archived materials also include histology slides, tissue blocks, and preserved specimens. An index of archived records ensures efficient retrieval.
Retention Periods
Record retention periods vary by regulatory jurisdiction and product type, typically ranging from five to fifteen years after study completion. The FDA requires retention for at least five years after data submission, while pharmaceutical studies often require retention for the life of the product plus additional years. Electronic records must be migrated to current formats as technology evolves.
Withdrawal and Transfer
Records withdrawn from the archive must be documented with a signed withdrawal log indicating the records removed, the purpose, and the expected return date. When a study is transferred between facilities or sponsors, the archive records must be transferred with full documentation of the chain of custody. Both the sending and receiving facilities must maintain records of the transfer.
Conclusion
A robust archiving system is essential for long-term GLP compliance and regulatory audit readiness. Facilities must invest in appropriate storage infrastructure, establish clear procedures for record management, and plan for technological obsolescence of electronic records. Effective archiving ensures that critical study data remain available for regulatory review and future scientific use.
