The Parenteral Drug Association's long awaited revised edition of Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, is now available for purchase at the PDA on-line bookstore.

This Technical Report originally issued in 2005, provides guidance to the biopharmaceutical/pharmaceutical industry and regulators on the essential principles and practices for shipment of products which require controlled temperature during transit. It also provides a design approach to the development of specialized packages and systems which will protect temperature-sensitive products during transportation. The 2007 Revision, prepared by PDA Temperature-Controlled Pharmaceuticals Group (TPG) – Harmonization Task Forcehas been updated and harmonized to reflect new global requirements.

Active PDA members will receive a complimentary hard copy of this new technical report with their July/August 2007 PDA Journal.