[afro-nets] WHO Public review of requirements for storage & transport of heat sensitive products

["Jakes Rawlinson" <brajakes@gmail.com>]

Cross-posted from: E-Drug@healthnet.org <E-Drug@healthnet.org>

Public Review: Model requirements for storage & transport of heat sensitive products

 WHO has a guideline out for public review of principal requirements for the safe storage and distribution of time and temperature-sensitive pharmaceutical products,

 They are seeking your comments - deadline for comments 31 July.
 More information, along with a printable pdf. file of the final draft, can be downloaded here.
 http://www.who.int/immunization_standards/public_review/en/index.html

 This guideline sets out the principal requirements for the safe storage and distribution of time and temperature-sensitive pharmaceutical products (TTSPPs).  It is based upon existing regulations and best practice guidance from a wide range of international sources, whilst accepting that local legislation and regulations will continue to take precedence.

 The target audience includes regulators, logisticians and pharmaceutical  professionals in industry, government and the international agencies.

 The document has been prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management which has been central to the review process. It has also been reviewed widely outside the Task Force, through various international cold chain conferences organized by Parenteral Drug Association (PDA), International Quality and Productivity Centre (IQPC) and International Pharmaceutical Academy (IPA).

 The intention is that the listed requirements should be directly applicable  in less developed countries as well as in the industrialized world. To this  end, supplementary materials will be developed to show how the requirements can practicably be achieved, particularly in resource-constrained settings.

 The document is designed to give a balanced overview of the major aspects of good storage and distribution practice for TTSPPs. As such it deliberately includes references to requirements which can be found in general guides to Good Manufacturing Practice (GMP), Good Storage Practice (GSP) and Good Distribution Practice (GDP). The purpose is not to supplant these source materials, but to ensure that the reader is aware of the relevant GMP, GSP and GDP implications when seen from the particular and specialized perspective of TTSPP management.

 The document will be available for download and comments until 31 July 2010.  The final version will be prepared incorporating comments received from this public review. The document will then be submitted to Experts Committee on Biological Standardization (ECBS) and Experts Committee on Specifications for Pharmaceutical Products (ECSPP) in October 2010.

 The Performance, Quality and Safety (PQS) group would greatly appreciate receiving your comments. All comments should be sent to Dr Ümit Kartoglu either by email (kartogluu@who.int) or fax (+41 22 791 4384).

 The document is marked with line numbers. When commenting, please indicate the page and line numbers for easy referral.

-- 
Dr JL Rawlinson
Department of Community Health / Public Health Medicine
Polokwane Mankweng Hospital Complex
University of Limpopo
Polokwane
South Africa
+27-15-287 5331 (W)
+27-82 410 9524 (Mobile)
+27-86-664 6262 (Fax)
mailto:brajakes@gmail.com