Maintaining and proving the cold chain from receiving to dispatch is essential to comply with current regulations. This guide compiles best practices for storage under controlled and refrigerated temperature, focused on medicines and related healthcare products, with room—when applicable—for other temperature-sensitive materials.
Best practices for storage
- Qualified infrastructure: 2–8 °C cold rooms and 15–25 °C / 15–30 °C controlled areas with thermal mapping, qualification (IQ/OQ/PQ), and traceable calibration of instruments.
- Continuous monitoring: continuous temperature reading (and, when applicable, humidity), configured alarms, and exportable records for inspections.
- Traceability and documentation: identification by batch/serial number, inbound/outbound history, and standardized records for critical steps (receiving, storage, dispatch, returns, recall).
- Processes and people: clear SOPs, periodic training by role and risk, change control, and CAPA (corrective and preventive actions) to address findings and prevent recurrence.
- Security and integrity: individual access control, CCTV in critical areas, and physical segregation by temperature range and risk.
Evidence that supports compliance
In inspections and audits, it is common to request:
- Updated qualification and thermal-mapping reports;
- Calibration certificates for sensors/data loggers;
- Continuous monitoring records with an audit trail (date, time, device, responsible person);
- Deviation investigation files with impact assessment and corrective actions;
- Training records and the team’s competency matrix.
What to assess when choosing a storage partner
- Evidence of thermal qualification and mapping;
- 24/7 monitoring with a data-retention policy;
- Document traceability that’s easy to extract (reports by batch/serial);
- SOPs covering receiving → dispatch → returns → recall;
- Physical security (controlled access and CCTV) in critical areas;
- Periodic training and a recent audit history with closed CAPAs.
Safelab acts as a trusted partner for storage under controlled and refrigerated temperature and, when needed, also integrates transport in a one-stop-shop model. We handle end-to-end: facility qualification, continuous monitoring, standardized records, document traceability, and audit preparation—with a primary focus on medicines and related products, and proportional application to other temperature-sensitive items.
Let’s talk about your scenario and design a clear plan to turn regulatory requirements into consistent evidence and operational predictability.
