HERBAL PRODUCT REALIZATION IN ACCORDANCE WITH WHO AND ISO GUIDELINES

Background: Following the Alma-Ata Declaration of 1978, the World Health Organization (WHO) began the issuance of guidelines for developing standardized herbal preparations from Traditional Medicine (TM). Similarly in 1987, the International Organization for Standardization (ISO) launched the most anticipated industrial standard (ISO 9001) in world history. The seventh (7^th) clause of ISO 9001’s eight clauses is devoted to “Product Realization”- a quality management system (QMS) procedure that includes: planning of product realization; appreciation of customer-related processes; design and development processes; purchasing; production and service provision; and control of measuring and monitoring equipment.

Purpose: The article takes a hard look at the QMS processes involved in product realization and the critical stages of the WHO model of herbal drug development from TM, with a view to devising a framework that can be used to promote the production of quality herbal products, commencing from the stage of ethnobotanical survey, through the laboratory, to the clinic.

Methodology: Both the WHO model of herbal drug development and the 7^th clause of ISO 9001:2008 were critically reviewed and combined to yield a framework that is discussed within the context of guiding herbal drug development from TM.

Results and Discussion: The resulting WHO-ISO framework of herbal product realization is discussed in terms of its relevance to practical problems of GMP-production using herbal starting materials, given their innate variability in composition, potency and appearance.

Conclusion: The provisions of ISO 9001’s seventh clause can, to a large extent, be applied to the production of quality herbal products developed in accordance with WHO.