The key to successful stability storage

Sylvain Darondel, Business Unit Manager BioPharma Stability Storage, Eurofins BioPharma Product Testing France

Key Guidelines and Standards

Stability studies are governed by numerous standards, such as those from the WHO, EMA, ICH, GMP, GDP, and FDA, among others. However, no single guideline comprehensively addresses all aspects of storage and logistics, emphasising the need for a systematic approach. 

Storage Approach

Using the Ishikawa method, six key factors are addressed:

1. Environment: Secure buildings with temperature control, pest control, and monitoring systems.
2. Methods: Clear procedures and documentation for sample management, equipment maintenance, and disaster recovery.
3. Manpower: Defined roles (e.g., project managers, technicians) and targeted training ensure proper execution.
4. Materials: Detailed study protocols outline objectives, storage conditions, and analysis schedules.5.
5. Machines: Equipment must meet specific storage conditions, be properly qualified (IQ, OQ, PQ), and have backups.
6. Measurements: Validated monitoring systems ensure compliance with storage conditions and manage alarms

Logistics of Stability Samples

Internal and external flows must be adapted to specific temperature requirements. Properly documented processes include using cold rooms or insulated trolleys for sensitive samples and qualified transport solutions for external shipments. International logistics require special attention to customs formalities.

Case Study

A stress study on an injectable product demonstrated the importance of validating multiple conditions, managing large storage volumes, and ensuring controlled transport.

Conclusion

Effective stability sample management involves adhering to regulations, leveraging the Ishikawa method for storage, and ensuring seamless logistics. This structured approach ensures reliable results in stability studies.