ISO 19617:2018

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

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.

Médecine traditionnelle chinoise — Exigences générales relatives au procédé de fabrication des produits naturels

General Information

• Status: Published
• Publication Date: 11-Apr-2018
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 12-Dec-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 19617
First edition
2018-04
Traditional Chinese medicine —
General requirements for the
manufacturing process of natural
products
Médecine traditionnelle chinoise — Exigences générales relatives au
procédé de fabrication des produits naturels
Reference number
ISO 19617:2018(E)
©
ISO 2018

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ISO 19617:2018(E)

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© ISO 2018
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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ISO 19617:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Assurance of manufacturing process . 6
4.1 Premises . 6
4.1.1 General. 6
4.1.2 Storage areas . 6
4.1.3 Production areas . 6
4.1.4 Sanitation . 7
4.2 Documentation . 7
4.2.1 General. 7
4.2.2 Crude drugs . 7
4.2.3 Finished traditional Chinese medicinal products . 8
4.2.4 Crude drug preparations . 9
4.2.5 Processing instructions . 9
4.3 Personnel .10
4.3.1 General.10
4.3.2 Crude
...