In addition to intrinsic stability, the type of packaging can significantly affect quality at end-user level. No specific problems of packaging such as quality or integrity of the container were identified in any of the products studied. A deficiency in cautionary labelling (refrigerated storage) was corrected during the course of the study in the case of ergometrine.
Temperatures of storage measured in drug store-rooms at the time of sampling reached a maximum value of 35°C and relative humidity was no more than 50%. Factors such as facility type, climate, transport method and distribution route were not found to significantly influence outcome. However, these were assessed in relation to fail rate, which is a crude indicator. The effect of exposure on assay values (parametric tests and multivariate analysis) is beyond the scope of this report. The degree of adverse exposure in Zimbabwe is less than seen in Sudan, where most other longitudinal stability studies have been performed,