Stability of Essential Drugs in Tropical Climates: Zimbabwe - EDM Research Series No. 013
(1994; 86 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAbbreviations
Ver el documento1. Summary
Abrir esta carpeta y ver su contenido2. Introduction
Abrir esta carpeta y ver su contenido3. Study design and methods
Ver el documento4. Results
Abrir esta carpeta y ver su contenido5. Discussion
Cerrar esta carpeta6. Conclusions and recommendations
Ver el documento6.1 Initial quality of drugs
Ver el documento6.2 Stability of drugs
Ver el documento6.3 Factors influencing the quality of drugs
Ver el documento6.4 Outcome of the study
Ver el documento6.5 Practical recommendations for a quality assurance system
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoAnnexes
 

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,

Ir a la sección anterior Ir a la siguiente sección
 

Última actualización: le 3 mayo 2013