Quality assurance of herbal raw materials in supply chain: challenges and opportunities.

The herbal medicine industry is presently adopting modern scientific tools to substantiate the guarantee of efficacy that, in the past, rested only on anecdotal evidence derived from traditional knowledge systems. This is particularly true for the processes of identification of herbal raw materials adopting modern tools for phytochemical fingerprinting. The successful adaptation of available technologies and practices depends on an understanding of the phytochemical complexity and variability innate in biological material. It challenges the "mainstream medicinal mindset" that "tend(s) to reject …. therapies for which mechanisms of action do not fit within Newtonian, biochemical orientation" (Dumoff, 2003). The herbal medicinal industry is independently evolving its own rigid quality assurance and control systems using Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) guidelines, but it faces unique difficulties. These include lack of Good Agricultural and Collection Practice (GACP), lack of transparency in the raw material supply chain so as to preclude the use of unsafe practices, problems in the authentication of herbal raw materials, and a general lack of understanding of the need to reduce phytochemical variability in these materials. This paper explores these difficulties and outlines strategies to overcome them, but these strategies will require coordinated international government regulations to be fully effective.