BS ISO 19617:2018,Traditional Chinese medicine — General requirements for the manufacturing process of natural products.BS ISO 19617:2018 pdf free download.
BS ISO 19617:2018 specifies the general requirements for manufacturing processes to ensure the quality of finished products used in traditional Chinese medicine (TCM). This document covers premises, documentation, personnel, training, manufacturing control and quality control. This document applies to the manufacturing of natural products used in and as TCM.
BS ISO 19617:2018 does not conflict with general pharmaceutical good manufacturing practices (GMPs).
BS ISO 19617:2018 applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.
Natural products used in traditional Chinese medicine (TCM) are manufactured from materials of natural origin, the quality of which is varied according to geographical, climatic and seasonal conditions. For quality assurance of final products, quality evaluation on starting materials for natural products used in TCM is essential. On the other hand, it is also important to handle these natural materials appropriately and to control manufacturing processes for natural products used in TCM.
These general GMPs were extensively applied to different fields and complimented with special supplements for herbal medicines in some countries and organizations. However, these herbal GMPs are focusing on European herbal medicines, but not covering those in the East Asian regions such as China, Japan and Korea where traditional medicines are used.

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