World Health Organization Guidance on the Storage and Transport of Temperature Sensitive Pharmaceutical Products
Background
The World Health Organization (WHO) publish guidelines for the storage and transport of temperature sensitive pharmaceutical products. Many pharmaceuticals, drugs and vaccines have time and/or temperature dependent requirements. The WHO guidelines are based upon existing worldwide regulations and best practices. Local regulations, policies and directives will take precedence over the WHO guidelines. However, in the absence of clear local directives, the WHO guidelines form the basis of best practices in the storage and transport of temperature sensitive pharmaceutical products.
These guidelines are aimed at the pharma logistics industry, pharmaceutical professionals and governments when formulating policies.
Importation and customs clearance
Time and temperature sensitive pharmaceuticals should be imported through ports of entry that are equipped to handle such products. After offloading, the time spent dockside or at the airport apron should be minimized with the pharmaceuticals being transferred to a proper temperature-controlled storage environment as quickly as possible. This temporary storage provides proper environmental conditions while awaiting official entry and customs clearance. Customs clearance delays can be avoided by pre-clearance, or using a customs clearing agent who is familiar with handling pharmaceuticals. This minimizes the chance of temperature excursions taking place.
Warehousing
After clearance, the time and temperature sensitive pharmaceutical products should be transferred to proper safe storage with environmental controls. The location of the warehouse should be carefully selected to minimize damage from flooding and other natural disasters.
The warehouse should be purpose-built and designed for the storage of time and temperature sensitive pharmaceuticals. If not, the adaptation of existing facilities should be for this specific purpose. The design should also consider the prevailing climatic conditions of the location, to ensure energy efficiency and minimize power consumption.
The loading and delivery bays of the warehouse should be designed to avoid the temperature sensitive pharmaceutical products from exposure to direct sunlight, dirt, dust and rain.
Warehouses designed for the storage of time and temperature sensitive pharmaceuticals should also contain a quarantine area. This is for the storage of rejected, faulty, recalled pharmaceutical products. For example, if a temperature excursion is found to have taken place, the compromised products can be held in this area.