ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products

This document specifies requirements for the inner pack of decoction pieces of Chinese medicines, including packaging materials, physical properties, specifications and labels. This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision and management of inner pack of decoction pieces.

This document specifies the testing of preservatives and unwanted compounds within a quality control framework for starting materials and finished products used in and as traditional Chinese medicine.

This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).

This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.

This document specifies the method for the determination of benzopyrene content in processed natural products. It is applicable to processed natural products such as processed Rehmannia root, processed Cyperus rhizome, processed ginseng and processed mume fruit. It is not applicable to the analysis of minerals used in traditional Chinese medicine.

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

This document specifies test methods to determine microorganisms in natural products. It is applicable only to natural products used in traditional Chinese medicine, including raw materials, herbal pieces and preparations.

This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

This document specifies the methods for the determination of aflatoxins (AFB1, AFB2, AFG1, AFG2) in natural products using LC-FLD. It is applicable to the analysis of aflatoxins in raw materials and manufactured products, including decoction pieces derived from plants and animals.

This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.

This document specifies methods for the determination of the selected Aconitum alkaloids, including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl-yunaconitine and crassicauline A.

This document specifies the method of determination of pesticide residues in natural products used in traditional Chinese medicine (TCM) by gas chromatography (GC), including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants.

This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicinal materials.

ISO 21371:2018 specifies general requirements for the labelling of products intended for oral or topical use in and as traditional Chinese medicine (TCM). ISO 21371:2018 is applicable to all finished manufactured products including packaged herbs used in and as TCM. This document includes the essential and informative elements for labelling of products to assist in the choice and safe use of these products by consumers and practitioners. NOTE A list of TCM labelling requirements of the WHO and various regions and countries is given in Annex A.