Good manufacturing practices in the Kenyan pharmaceutical industry and impact of facility upgrading on domestic and international sales

Good Manufacturing Practice is the main regulatory standard for ensuring pharmaceutical quality. Manufacturers are required to comply with this standard to warrant medicines which do not pose risk to consumers. The aim of this study was to assess compliance of Kenyan pharmaceutical industry with Good Manufacturing Practices and to determine the impact of facility upgrading on domestic and international sales. Information on key quality elements was collected from 16 manufacturers using a structured questionnaire. Data on domestic and export sales for two upgraded facilities was evaluated for the period, 2010 to 2014. Compliance with Good Manufacturing Practices varied amongst the facilities; all had local accreditation, 11 were accredited by Drug Authorities in East Africa region and 3 held international certification. Domestic sales for two facilities declined after upgradation and international sales increased fivefold for the facility accorded international accreditation. Upgrading of facilities improved international trade but negatively impacted domestic sales.Keywords: Compliance, manufacturing, pharmaceutical, sales, upgradin

Production capacity of the pharmaceutical manufacturing industry in Kenya

This study aimed to determine the production capacity in the Kenyan pharmaceutical industry and to forecast the year for full capacity utilization. Data was collected on installed, available and utilized capacities in this industry for the period 2010–2014, using a structured questionnaire. Six dosage forms namely tablets, capsules, oral liquids, external preparations, dry powders and oral rehydration salts were evaluated. Projection of capacity utilization was performed using time series forecasting method. The available capacity in billions was 29.3 tablets, 2.3 capsules, 0.4 bottles of oral liquids, 0.1 tubes of external preparations, 0.1 bottles of dry powders and 0.1 sachets of oral rehydration salts. In 2014, the overall utilized capacity was 27.4 %. The study showed that production capacity was underutilized. However, overall utilized capacity increased steadily during the five years. The forecasted year for achieving full capacity utilization for the manufactured dosage forms was 2043.Keywords: Pharmaceutical manufacturing, production capacity, installed, utilize