The need for good practices in biomedical technology.
The present modern technologies have made it possible for one to carry out intricate and highly sensitive procedures that in the past were impossible or unheard of. The pharmaceutical industry has provided sophisticated products with unique drug delivery systems. Instrumentation technology has made it possible for the production of machines and facilities for use in the diagnosis and management of disease. Clinical science has reached such high levels of achievement as to enable an efficient patient management. Scientists and professionals working in these fields have thus been provided with modern tools with which to provide more efficient service to mankind. But consumers having become as equally sophisticated as these advancements, also require to know whether these products, equipment and services are fail-safe. They demand assurance; as it were, quality assurance. Gone are the days when the health professional would maintain his/her absolute competence, the pharmacist would assert that the pharmaceutical product was perfect, the laboratory analyst would claim that the laboratory results were excellent, and the physician would sternly uphold his clinical supremacy. Now, it is well known that there are no such ideals in health science research and practice. To try to attain the best level possible, professional bodies all over the world have established guidelines for Quality Assurance, Accreditation and Certification. The International standards Organization (ISO) has formulated comprehensive standards for all forms of quality audit and certification. The five quality management standards of the ISO, known as ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004, have been adopted by many organizations in various countries of the world. The principles of Good Laboratory Practices (LP) which were initially formulated by the Food and Drug Administration (FDA) of the USA was adopted by the European Union (EU) in 1989. The World Health Organization (WHO) has also issued Guidelines for Good Clinical Practice (GCP), Guidelines for Good Manufacturing Practices (GMP) of Pharmaceuticals, and Guidelines for the Production of Biologicals. It is thus evident that quality assurance is a very important aspect in all fields of health science research and practice. Quality assurance embraces quality control and audit and involves three things: personnel and material resources, quality system structure, and management responsibilities. Well trained personnel are required to use the appropriate materials and tools, an efficient quality system structure is desirable, and a good management system to implement the quality assurance programme is very essential. This programme should also enable the providers of goods and services to be bold enough to disclose to the consumers when their goods and services fail, as in the recent case of Abbot Laboratories when they had to withdraw their HIV test kit from the market after failing to meet the prescribed standards. Similarly, some years ago the anti-inflammatory drug Benoxaprofen (ORAFLEX-Eli Lilly) was withdrawn shortly after its introduction in the clinic. Do the organisations in Africa have the capacity to develop, or adopt, a quality assurance programme? It is fair to answer in the affirmative Organisations in Africa can, and should, adopt any of the existing quality assurance programmes that suit their operations best. What is most important is that operations must have the means to establish specificity, accuracy, precision and sensitivity that can be verified and certified. The big question is, do all these nicely worded standards, guidelines and practices have uniform and enforceable laws that enable their effective implementation and protection of the consumers?
Koech
D K
DK
Kenya Medical Research Institute, P.O. Box 54840, Nairobi, Kenya.