Who guidelines for herbal manufacturing : challenges and opportunities
2000
Zhari Ismail
The handling of herbal products for manufacture requires a culture quite different from conventional pharmaceutical drug manufacture. The control of the crude raw materials, its storage and processing takes priority in view of the complex and variable nature of its components as well as the number and small quantity of defined ingredients present. The WHO Guidelines for herbal manufacture have very clear rulings. They outline the nature of premises which differentiates the storage and production areas, documentation specifications for starting materials, qualitative and quantitative requirements of plant materials and plant preparation, specifications for the finished product and processing instructions. Trained personnel for identification tests, adulteration checks involving microscopy and chromatography, and other pharmacognosical tests, must handle quality control. Advice on sampling is given and test indicating stability of constituents present in the plant materials are also included. In our Malaysian context, the emphasis on implementing the GMP (Good Manufacturing Practices) in the herbal industry is among the challenges faced. This involves the complete understanding of the theory and practices of herbal science and technology which encompass several disciplines and requiring local research and development. The nature and amount of local scientific and technological input serves as milestones for the current status of the Malaysian herbal industry. Correct policies and strategies relating to infrastructure development, funding, human resource development, sourcing of standard plant materials and herbal manufacturing technology are some of the issues needing attention. These are also the potential areas where opportunities await to be tapped by those having the right expertise. This paper highlights the above mentioned issues.
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