WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products

Recommendation

6/7 November 2024

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Temperature controlled Transports of Medicinal Products

During The 137th World Health Organisation (WHO) Executive Board (EB) meeting, the Report of the 49th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations was presented. With this report, a set of new guidances was adopted and recommended for use, in addition to certain monographs and general texts for inclusion in The International Pharmacopoeia. The report is now available in the WHO Technical Report Series as No. 992.

For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products.

This series of technical supplements intends to give further guidance and more details to the recommendations given in the Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011, Annex 9).This document focuses on principal requirements for the safe storage and distribution of time- and temperature sensitive pharmaceutical products (TTSPPs).

The additional material provided in these supplements links back to a specific clause or clauses in the parent document mentioned above. All of the 16 single documents contain a reference section with hyperlinks to relevant supporting materials. This gives a great overview on what is the current state of the scientific and technical knowledge in this area.

Here are the links to the single documents:

• Supplement 1: Selecting sites for storage facilities
• Supplement 2: Design and procurement of storage facilities
• Supplement 3: Estimating the capacity of storage facilities
• Supplement 4: Building security and fire protection
• Supplement 5: Maintenance of storage facilities
• Supplement 6: Temperature and humidity monitoring systems for fixed storage areas
• Supplement 7: Qualification of temperature-controlled storage areas
• Supplement 8: Temperature mapping of storage areas
• Supplement 9: Maintenance of refrigeration equipment
• Supplement 10: Checking the accuracy of temperature control and monitoring devices
• Supplement 11: Qualification of refrigerated road vehicles
• Supplement 12: Temperature-controlled transport operations by road and by air
• Supplement 13: Qualification of shipping containers
• Supplement 14: Transport route profiling qualification
• Supplement 15: Temperature and humidity monitoring systems for transport operations
• Supplement 16: Environmental management of refrigeration equipment