PRODUCT REALIZATION AND SERVICE PROVISION IN HERBAL DRUG RESEARCH AND DEVELOPMENT ACCORDING TO ISO 9001

Abstract

Author(s): Ameh Sunday, Garba Magaji, Gamaniel Karniyus

Background: Product realization according to the International Organization for Standardization (ISO) includes: planning of product realization; customerrelated processes; design and development; purchasing; production and service provision; and control of measuring and monitoring equipment, as specified in the 7 th clause of ISO 9001. Purpose: The article takes a critical look at product realization as per ISO 9001and the critical stages of herbal drug research and development (R&D) from traditional medicine (TM), with a view to synthesizing a framework that can be used to introduce quality into herbal products from the stage of ethnobotanical survey, through product conception and development, up to the stage of clinical trials. Methodology: The provisions of the 7 th clause of ISO 9001 and the WHO model of herbal drug R&D as adopted by the Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) were determinatively reviewed and fused to yield a framework which is then discussed in the context of guiding herbal drug R&D from TM. Results and Discussion: The resulting tabular framework is discussed in terms of the applicability of the provisions of the 7th clause of ISO 9001 to the critical stages of herbal drug R&D at NIPRD, with the aim of introducing quality into herbal drug products. Conclusion: The provisions of ISO 9001’s 7th clause can be applied, albeit selectively, in introducing quality to herbal drug products developed from traditional herbal medicine