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
Current Stage
9092 - International Standard to be revised
Completion Date
12-Dec-2023
Ref Project

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ISO 19617:2018 - Traditional Chinese medicine -- General requirements for the manufacturing process of natural products
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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)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
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
...

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