Quality Assurance & Stability Testing of Herbal Drugs

U.S. consumers spend about $34 billion every year on alternative medicines, with 44 percent of those dollars buying supplements like echinacea and glucosamine, according to a 2007 government survey. Adequate quality assurance can protect buyers from potential negative side effects of herbal medicines and let consumers know of any contraindications from mixing herbal and chemically-based drugs.

Quality Assurance Standards

• The World Health Organization issued guidelines in 2004 on product quality for herbal medicines and supplements. In order to assure product quality, WHO said, makers of herb-based medicines have to follow established standards that specify documentation of herbal testing and development. These standards include Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices and Good Laboratory Practice.

GACP Enforcement Agency

• The WHO guidelines recommend that every nation growing plants for herbal medicine production have an agency to regulate Good Agricultural and Collection Practices. Such an agency contributes to end-product quality by identifying the best growing soil, seeds, appropriate pesticides and fertilizers. The agency could also help companies choose the best harvesting and processing machines.

Licensing Distributors

• The World Health Organization advises that after plant growth is regulated, distribution to the public should be monitored closely. A nation's drug regulating authority should screen distributors and issue licenses to manufacturers, assemblers, wholesalers and importers of herbal medicines. License type would be issued according to business type. Manufacturers of Evergreen Herb International, Ltd. in Australia and China are licensed by their national governments for compliance with recognized good manufacturing practices. Licensure guarantees that the facilities are continually inspected by regulatory agencies for sanitation, documentation, personnel training and storage and release processes.

Quality Assurance Example

• Himalaya Herbal Healthcare explains that to assure the quality of its products, the company only uses raw materials that meet its standards. Second, only manufacturing processes delineated in the company's standard operating procedures are used. Finally, chemical "fingerprints'' of the herbs are taken to identify chemical properties and authenticate that they are genuine.

Stability Testing

• The World Health Organization recognizes that due to the widespread use of herbal medicines, testing them for stability can only be accomplished if each herb manufacturer's country establishes a safety monitoring program that works in conjunction with a national drug regulatory system. To test for safety and herbal medicine stability, a monitoring program must identify the origin of negative side effects, learn how to manage risks, implement measures to prevent adverse outcomes and effectively communicate benefits and risks to the general public.