Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.

OBJECTIVE To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. DESIGN Cross-sectional study. SETTING Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. INTERVENTIONS Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. MAIN OUTCOME MEASURES The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. RESULTS There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private pharmacies stocked few of the locally manufactured products. The reason, they said, was due to low doctor and/or patient acceptance. Compliance with quality specifications as set out in respective monographs was overall 76%. CONCLUSION Although the local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products currently in commerce, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them.