Stability of Essential Drugs in Tropical Climates: Zimbabwe - EDM Research Series No. 013
(1994; 86 pages) View the PDF document
Table of Contents
View the documentAbbreviations
View the document1. Summary
Open this folder and view contents2. Introduction
Open this folder and view contents3. Study design and methods
View the document4. Results
Open this folder and view contents5. Discussion
Close this folder6. Conclusions and recommendations
View the document6.1 Initial quality of drugs
View the document6.2 Stability of drugs
View the document6.3 Factors influencing the quality of drugs
View the document6.4 Outcome of the study
View the document6.5 Practical recommendations for a quality assurance system
View the documentReferences
Open this folder and view contentsAnnexes
 

6.5 Practical recommendations for a quality assurance system

1. Testing for initial quality should be given high priority. Routine testing of new suppliers is recommended.

2. Even in the case of manufacturers with a proven good record, selective sampling of particular drugs is recommended. This study suggests that epinephrine injection, ampicillin injection and retinol tablets could be good markers for intrinsic quality problems. Other drugs should be considered according to the specific relevance in the country. The inclusion of tetracycline capsules or doxycycline capsules is advisable.

3. The prequalification of suppliers is recommended. This is considered essential in the case of ergometrine injection. Every batch should be tested upon receipt (at least a visual discoloration test).

4. Specifications at the time of tendering should include an adequate (but proven acceptable) shelf-life, and detailed packaging requirements and special labelling as relevant.

Occasional field sampling of drugs suspected to be vulnerable (such as ergometrine injection or other injectable in liquid formulation) is justified; "worst case" samples should be sought. The general testing of samples at the facility level is not recommended.

 

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Last updated: May 3, 2013