E-DRUG: Appropriate Stability Testing of Pharmaceuticals
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In Appendix 1 'Stability testing of active pharmaceutical ingredients and finished pharmaceutical products' in the WHO Technical Report Series No. 953, 2009 publication there is presented in Table 2 a listing by countries of the Stability conditions, Confirmed long-term testing condition. Almost all of the member states of the Regional Office for Africa (AFRO) cite 30 degrees Celsius at 65 or 75% RH; the exceptions are Algeria, Botswana, Malawi, and Swaziland which list 25 degrees Celsius.
The publication is available at: http://www.aapspharmaceutica.com/inside/Focus_Groups/Stability/imagespdfs/WHO%20Stability%20Guideline%202009.pdf
It is striking how few suppliers furnish products appropriately stability tested for those markets. Products stability tested and labeled for the WHO Climatic Zones I/II markets are not appropriate for these Climatic Zone III/IV markets and should not receive marketing authorizations for them unless the firms supply a guarantee that their products will meet their quality standards at expiration if stored under the cited conditions for their country.
Thomas Layloff, Ph.D.
Senior Quality Assurance Advisor
Supply Chain Management System
1616 N. Fort Myer Drive, 12th Floor
Arlington, VA 22209-3100
Direct Tel: +1.571.227.8608,
tlayloff@aol.com