With the ever-increasing use of herbal medicines and the global expansion of the herbal medicines market, safety has become a major concern for both health authorities and the public in many countries.

The quality of herbal medicines has a direct impact on their safety and efficacy. There are many control measures for herbal medicines, and the fi rst important step is to control the quality of medicinal plants and herbal materials. However, this is a very complicated and diffi cult task as it involves many different areas, such as the environment and agricultural practices.

It is well known that there are many contaminants and residues that may cause harm to the consumers of herbal medicines. Many are natural, such as naturally occurring radionuclides, toxic metals or bacteria. Some arise from past or present use of agents or materials that pollute the environment and subsequently medicinal plants, such as emissions from factories or the residues of certain pesticides.

Compliance with GACP and GMP is crucial for the production of good quality herbal medicines. The entire production process, starting from cultivation and ending with the sale of the products, must adhere rigorously to these two sets of practices. The contents of these guidelines should therefore be read in conjunction with GACP and GMP in an effort to produce quality products for the local and international markets.

Foreign matter found in a sample of herbs and herbal materials should not exceed limits set in national, regional or international pharmacopoeias. Foreign matter includes insects and other animal contamination including animal excreta, as well as other species of plants.

The maximum amounts of toxic metals and non-metals in medicinal plant materials can be given based on the provisional tolerable intake (PTI) values. These values should be established on a regional or national basis.

Mycotoxins and, when appropriate, endotoxins should be tested for using an appropriately validated and sensitive method, and amounts should be below the limits set in national or regional standards.

Attachments:

Contaminants.pdf

[With the ever-increasing use of herbal medicines and the global expansion of the herbal medicines market, safety has become a major concern for both health authorities and the public in many countries.]

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