Orwa J A, Keter L K, Ouko S P A, Kibwage I O, Rukunga G M
Center for Traditional Medicine and Drug Research, Kenya Medical Research Institute, PO Box 54840, Nairobi, Kenya.
East Afr Med J. 2004 Jun;81(6):287-92. doi: 10.4314/eamj.v81i6.9177.
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.
Cross-sectional study.
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.
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.
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.
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%.
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.
确定肯尼亚各制药企业生产的药品质量，并判定生产规范对这些产品质量的影响。
横断面研究。
研究的企业位于肯尼亚内罗毕。利用肯尼亚医学研究所和内罗毕大学药学院的现有设施进行实验室分析。
采用结构化问卷，调查各公司在每种药品生产过程中如何运用药品生产质量管理规范。向社区药房发放问卷，以评估药品的分销情况并开展有限的上市后监测研究。按照各自的药典对药品进行抽样和质量分析。
向企业发放的问卷包括原材料来源、生产前后的检疫程序、生产程序、质量审核、质量保证程序、设备和人员。向药房发放的问卷包括本地生产药品的可得性、可承受性和可接受性。产品质量分析包括确定化学含量、溶出曲线、脆碎度、重量均匀度和鉴别。对于抗生素混悬液，还测定了复溶后的稳定性。
企业方面有15名受访者和2名未回复者，药房方面9名受访者中有6名回复。合格员工与所生产产品种类的比例似乎会影响产品质量。与只生产少数产品的企业相比，生产多种产品但制药员工数量有限的企业有更多产品不符合药典规范。不过，所有公司都根据所生产产品的类型配备了完善的质量控制设备。私立药房很少储备本地生产的药品。他们表示，原因是医生和/或患者的接受度较低。总体而言，符合各药典规定质量标准的比例为76%。
尽管当地制药企业已采用药品生产质量管理规范，目前市面上有许多高质量产品，但这些生产规范并不全面，需要采取措施持续改进。
