Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


Requirements for stability studies - new WHO requirements@Tue. 30 Mar. 2010


Dear Colleagues:

Please be advised that the World Health Organization (WHO) has just announced a change to their inspection of stability data when performing a pre-qualification evaluation and GMP inspection. Their announcement states:

Stability data must demonstrate stability of the medicinal product throughout its intended shelf-life under the climatic conditions prevalent in the target countries. Merely applying the same requirements applicable to other markets could potentially lead to substandard products, e.g. stability studies conducted for countries in Climatic Zone I/II when the products are supplied in Climatic Zones III and IV.

With effect from September 2011, when evaluating applications WHO will assume that all the medicines prequalified will be used in all sub-zones of Climatic Zones III and IV, unless otherwise properly justified by the applicant and confirmed by WHO.

With Best Regards,

Michael Anisfeld



Globepharm 313 Pine Street (Ste 204)

Deerfield IL 60015, USA

Ph: USA +1 847 914 0922

Fx: USA +1 847 914 0988

e-mail: consulting@globepharm.org






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