小中大
cuturl('http://apps.who.int/prequal/info_general/documents/stability/Stability_Requirements.pdf')
New requirement
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 (see diagram below with supply data per climatic zone). Therefore, in order to safeguard product quality throughout its entire intended shelf‐life, stability studies under the conditions defined for Climatic Zones IVb should be performed and the data submitted, i.e. the shelf‐life should be established based on complete* long‐term data at 30?C ±2?C/75% RH ±5% RH.
Furthermore, in order to aid procurement decisions, it is proposed that the conditions under which stability studies were performed and the established shelf‐life, will be included in the WHO List of Prequalified Medicinal Products
*”Complete” refers to the length of data required at the time of dossier submission.
