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ISO 19617:2018

Traditional Chinese medicine — General requirements for the manufacturing process of natural products

Publication date:   Apr 12, 2018

General information

90.92 Standard to be revised   Dec 12, 2023

ISO

ISO/TC 249 Traditional Chinese medicine

International Standard

11.120.10   Medicaments

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Scope

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.
ISO 19617:2018 does not conflict with general pharmaceutical good manufacturing practices (GMPs).
ISO 19617:2018 applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.

Life cycle

NOW

PUBLISHED
ISO 19617:2018
90.92 Standard to be revised
Dec 12, 2023

REVISED BY

IN_DEVELOPMENT
ISO/DIS 19617