RECOMMENDATIONS ON THE CONTROL AND MONITORING OF STORAGE AND TRANSPORTATION TEMPERATURES OF MEDICINAL PRODUCTS

Medicinal products and starting materials used in the manufacture of medicinal products should be stored and transported under conditions which ensure that their quality is maintained. Manufacturers’ recommendations concerning storage temperatures should be observed and this may involve the use of specialised storage and transport facilities. Temperature-monitoring devices should be used to demonstrate compliance with the designated temperature ranges. The distribution chain is seldom simple and distribution systems can vary enormously. In its simplest form, the chain involves shipment direct from the manufacturer to the customer or end user. In its more complex form, the distribution chain may involve a number of storage and transit locations, including airports and docks, and a variety of transport facilities, including aircraft. Good warehousing and distribution practices1 require that storage areas for medicines should be maintained within acceptable temperature limits and that, where special storage conditions are specified by the manufacturer, these should be provided, checked and monitored. Measuring and monitoring equipment should be calibrated and checked at defined intervals. Medicinal products should be transported in such a way that they are not subjected to unacceptable degrees of heat and cold, and specialised means of transportation should be used where necessary. There have been a number of open seminars and conferences on this subject in recent years. The Medicines Control Agency (MCA) has published guidelines for the pharmaceutical industry2 and the British Association of Pharmaceutical Wholesalers has introduced a protocol for its members.3 This article provides additional advice for the control and monitoring of temperatures during the storage, shipping and distribution of medicinal products.