Stringent quality controls for herbal products are absolutely necessary to ensure the maximum safety for treatment. Quite apart from the safety issue, strict quality controls are also extremely important to ensure acceptance of herbal medicine by the regulatory authorities. If it can be demonstrated that the herbal industry applies strict quality controls which ensure safety, this will constitute an important step towards acceptance of herbal medicine and may help to put an end to constant “sniping” regarding the alleged toxicity of herbs.

Quality controls for Chinese herbs should ensure the following:

• Correct identification of each herb.
• Checking that herbs are free of contamination from heavy metals, pesticides, aflatoxins and any foreign matter.
• Manufacturing according to GMP standards which ensure hygienic conditions and allow identification of each batch of production.

The quality controls governing The Three Treasures and Women’s Treasure remedies may be taken as an example of exemplary quality controls. These remedies are made in Taiwan by Kaiser Pharmaceutical Co. Ltd (KP). Kaiser’s modern scientific processing methods and standards of rigourous quality control set them apart from all other sources of Chinese herbs.

Each herbal remedy is made from good quality, fresh herbs. The raw herbs are first inspected for conformity and species verification by experienced botanists in Taiwan and Europe. Then volatile oils are removed, to be reintroduced later on. All the herbs for a single remedy are subsequently decocted together, rather than separately, greatly strengthening the synergy of the herbs. All of these processes take place in a closed and controlled environment.

The herbs then undergo several further processes to create the finished product: evaporation, the introduction of the collected volatile oils and the further concentration of the liquid extract, and then granulation, during which the concentrate is sprayed onto starch particles of the same herbs and is vacuum-dried at a low temperature. This takes place in a completely enclosed chamber to protect against cross-contamination. During the final process of formulation, the modified formulae, now in their dry granular form, are bottled and sealed. Labelling takes place in the UK under GMP (Good Manufacturing Practice) standards.

After processing, the remedies are subject to a number of strict quality controls. Each batch of every product is subject to a detailed and careful analysis to ensure a consistent and stable amount of active ingredients. The solubility and stability of each product is tested. Each product is tested for bacteria (for example, salmonella, col-bacteria and a total bacteria count), moulds and yeasts. High Performance Liquid Chromatography (HPLC) measures potency by substantiating the presence of active ingredients. Thin Layer Chromatography (TLC) (re) confirms identity by using a chemical fingerprint unique to each species. Each remedy also undergoes an analysis of heavy metal values known as Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). This state-of-the-art geophysical technology ensures absolute safety of each product, with reference to the limit values of the Japanese and European pharmacopeias. This system is sensitive to sub-parts per billion, compared to other systems which detect elements only in sub-parts per million. Gas Chromatography (GC) further ensures safety by testing for over 200 potentially harmful substances such as pesticides, herbicides and fungicides. Herbs susceptible to contamination by aflatoxins are tested separately.

Quality control is reflected in a final certificate which lists the botanical name of the herb and its organoleptic properties, all test results and relevant information.