Quality of some pharmacutical products manufactured in Kenya

Abstract

Samples of pharmaceutical products were obtained from local industries and retail outlets and evaluated with respect to six quality-indicating parameters, namely content, uniformity of weight, uniformity of diameter, friability, identity and dissolution. Out of 63 samples, compliance with quality specifications for content, dissolution and uniformity of weight was 92%, 82% and 73% respectively. All 13 samples tested complied with the test for identification and all the antibiotic suspensions tested complied with pharmacopoeia specification for stability test. There were products with too much and with too little active content identified from among the samples that failed to comply with respective pharmacopoeia limits for chemical content. This may indicate that failure to comply with specification for active content was probably not due to poor quality raw materials but rather to poor quality control during manufacturing process. Failure to comply with pharmacopoeia specification for dissolution and uniformity of weight may be attributed to problems in formulation procedures. Although most of the products examined showed general attributes of good quality, there are some cases where there is need for improved manufacturing practices to achieve product quality.