| dc.description.abstract | The production of substandard and counterfeit drugs as a result of non-adherence to good manufacturing practices by pharmaceutical companies is a vast and underreported worldwide problem particularly affecting developing countries. Developing countries are not only markets for substandard and counterfeit drugs, they also produce substandard and counterfeit drugs. Local pharmaceutical manufacturing companies in Zambia have not been spared from this vice. Counterfeit and substandard drugs have been associated with therapeutic as well as social and economic implications on the health of the individual, family, community and the nation at large. Unfortunately no research have been conducted in Zambia to determine the level of adherence to good manufacturing practices by local pharmaceutical manufacturing companies, hence this study.Objective:
The purpose of this study was to assess the quality of co-trimoxazole, fansidar and paracetamol tablets manufactured in Zambia and to determine the levels of adherence to good manufacturing practices and factors contributing to non adherence to GMP by local pharmaceutical manufacturing companies in Zambia.Study design:A Cross Sectional Descriptive study was conducted. All six local pharmaceutical manufacturing companies authorized to manufacture drugs in Zambia were assessed for compliance to GMP. Samples of co-trimoxazole, paracetamol and pyrimethamine sulphadoxine tablets available at the time of sampling were obtained from each pharmaceutical company provided they had a shelf life of at least three years. A sample was a sealed tin of 1000 tablets. The tablet were removed from their original containers and number coded before being taken to the Food and Drugs laboratory for analysis. However, the names, strengths, batch numbers, expiry dates and manufacturers' names were recorded. In total 126 co- trimoxazole, 126 paracetamol and 126 pyrimethamine sulphadoxine tablets samples were collected. A total of 10 members of staff at PRA were interviewed using a structured questionnaire. To compliment data from the GMP checklist and the questionnaire interviews were conducted to clarify certain issues.Methods and materials: Sample selection and collection.Selection of drug products in this study was based on their high usage and relevance to public health. Co-timoxazole, pyrimethamine/suphadoxine and paractamol tablets were chosen because they represent a relatively large proportion of the total drug usage and are all included in the Zambian essential drug list. Samples were collected from six local manufacturing companies. Drug quality was measured by level of active ingredient as percentage of stated content and by compliance (pass/fail) with assay standards of the British Pharmacopoeia volume (II) 1993. Adherence to GMP was measured by level of compliance (pass/fail) with standards of GMP outlined in GMP checklist.Results: For active ingredients determination, all of the paracetamol and pyrimethathine/sulphadoxine samples tested gave values that complied with the B.P specifications except for co-trimoxazole The uniformity of weight determinations for all
the samples gave values which complied with the B.P specification for weight uniformity, as none of the samples deviated by up to 5% from the respective mean values. Similarly, the tablet hardness, friability, moisture and water content results for paracetamol and pyrimethamine/Sulphadoxine. The samples also complied with B.P specifications except for co-trimoxazole.Conclusion: This study provides objective evidence to support frequent contentions that substandard drugs though in insignificant proportions are present in Lusaka. Drug sample marginally exceeded the B.P Pharmacopoeia limits on active ingredients content. Most likely these preparations are substandard not because of counterfeiting but as a result of absence of management control systems. This study showed a high degree of adherence to GMP by local pharmaceutical manufacturing companies in Lusaka. | en_US |
