Dr. Umit Kartoglu of the World Health Organization (WHO), presented the draft of the long awaited Harmonized Guidance for the Storage and Transport of Time and Temperature–Sensitive Pharmaceutical Products at the IQPC Cool Chain Europe 2010 Conference in Amsterdam, Netherlands last week.

The 41 page document consolidates regulations and guidance on the storage and distribution of temperature-sensitive pharmaceutical products from a wide range of international sources into a single, relatively short document. The guidance has been prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management whose members have been central to the review process.

The harmonized document is intended to gain general acceptance as an international guide to good practice in this field, whilst accepting that local legislation and regulations will continue to take precedence. The document is specifically intended to have wide-ranging applicability in developing countries as well as in the industrialized world. The target audience are regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies. Once the document has been completed, fully reviewed and approved, it will be supplemented by relevant practical guidance material showing how the requirements set out in the guideline can be achieved in practice. This guidance material will take specific account of resource and other constraints in the developing world but will also describe best practice in the industrialized world.

A pdf. of the entire draft document is attached for those interested in reviewing and commenting.

The comment period continues until March 15, 2010.

All comments should be directed to Dr. Kartoglu at kartogluu@who.int.