Stability of Essential Drugs in Tropical Climates: Zimbabwe - EDM Research Series No. 013
(1994; 86 pages) Voir le document au format PDF
Table des matières
Afficher le documentAbbreviations
Afficher le document1. Summary
Ouvrir ce répertoire et afficher son contenu2. Introduction
Ouvrir ce répertoire et afficher son contenu3. Study design and methods
Afficher le document4. Results
Ouvrir ce répertoire et afficher son contenu5. Discussion
Fermer ce répertoire6. Conclusions and recommendations
Afficher le document6.1 Initial quality of drugs
Afficher le document6.2 Stability of drugs
Afficher le document6.3 Factors influencing the quality of drugs
Afficher le document6.4 Outcome of the study
Afficher le document6.5 Practical recommendations for a quality assurance system
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuAnnexes
 

6.3 Factors influencing the quality of drugs

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,

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Dernière mise à jour: le 3 mai 2013