Standard: ISO - FDIS 19617

TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS FOR THE MANUFACTURING PROCESS OF NATURAL PRODUCTS

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Scope:

This document 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.

This document does not conflict with general pharmaceutical GMPs.

This document applies to all materials of natural origin: medicinal plants, medicinal animals, medicinal minerals, crude drugs or crude drug preparations.

Organization: International Organization for Standardization
Document Number: fdis 19617
Publish Date: 2018-01-03
Page Count: 26
Change Type: DRFT
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Pending
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