New WHO guidance for Storage and Transportation

The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 18 to 22 October 2010. Now, the respective technical report has been submitted to the WHO Executive Board and was published with a model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products:

"The Expert Committee was briefed about the history and steps involved in the development of this new guidance in the joint session with the Expert Committee on Biological Standardization. After making suitable amendments, the Expert Committee on Biological Standardization and the Expert Committee on Specifications for Pharmaceutical Preparations recommended that the Guidelines be adopted and appended to their respective reports. In addition the Expert Committee on Biological Standardization recommended:

  • that an addendum to the document be developed for labile blood products; and
  • that WHO considers providing guidance to national regulatory authorities on how to define transport requirements for time and temperature sensitive pharmaceutical products (TTSPP).

During the joint session with the Expert Committee on Biological Standardization it was recommended to refer to "suspect" products in section 8.5 to allow for dealing with problems related to the quality of the product not covered in other sections of the document."

The Expert Committee adopted the text with the changes proposed (Annex 9).

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