In a pharmaceutical wholesaler the cold chain is more than one temperature value: suitable areas, measured conditions and documented records work together, and if one is missing the other two do not carry an inspection. The main reference is the TİTCK Good Distribution Practice (GDP) Guideline for Medicinal Products of 2022.
Defined areas, working alarms and kept records make the cold chain auditable inside a pharmaceutical warehouse.
Areas
Receipt, dispatch and storage areas are clearly and physically separated from each other. Products removed from saleable stock or awaiting a decision, suspected falsified products and returns are separated physically and by an electronic system; expired, recalled and rejected products are kept apart from the rest in quarantine and rejection areas, and these areas are clearly marked.
Monitoring and alarms
A cold room is mapped empty before use, then loaded and by season, and monitoring devices go at the worst-case points. The alarm reaches the responsible people on any deviation from storage conditions, is tested regularly and also works when nobody is on site (a text message, an audible and visual alarm to responsible staff). The cooling system is backed up and serviced 24/7, a generator backs up the power, and measuring devices are calibrated at least once a year by TÜRKAK-accredited bodies.
Records and training
Records and backed-up data are kept at least 5 years, staff training is held at least once a year and its effectiveness is assessed and documented. The responsible manager approves every return to saleable stock.