ISO 23419:2021

INTERNATIONAL ISO
STANDARD 23419
First edition
2021-12
Traditional Chinese medicine —
General requirements for
manufacturing procedures and quality
assurance of granules
Médecine traditionnelle chinoise — Exigences générales relatives aux
modes opératoires de fabrication et à l'assurance de la qualité des
granules
Reference number
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements of manufacturing procedures . 3
4.1 General . 3
4.2 Crushing . 4
4.3 Extraction . 4
4.4 Liquid-solid separation . 5
4.5 Concentration and drying . 5
4.6 Granulation . 6
4.6.1 General . 6
4.6.2 Dry granulation . 6
4.6.3 Semi-dry granulation . 7
4.6.4 Wet granulation . 7
4.7 Compaction . 8
4.8 Packaging and labelling . 8
5 General requirement of quality assurance . 8
5.1 General . 8
5.2 Equivalency evaluation . 9
5.3 Identification . 9
5.4 Assay . 9
5.5 Particle size and particle size distribution . 9
5.6 Dissolution or disintegration test . 9
5.7 Determination of water or moisture content . 9
5.8 Uniformity of dosage units . 10
6 Requirements of safety tests .10
6.1 Pesticide residues . 10
6.2 Heavy metals . 10
6.3 Aflatoxins . 10
6.4 Microorganism . 10
Annex A (informative) Production, quality and selection of crude drugs .11
Annex B (informative) Particle size distribution .12
Annex C (informative) Equivalency evaluation .13
Annex D (informative) Determination of the content of methanol-soluble extractives .15
Bibliography .17
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
Herbal medicines used in traditional Chinese medicine have been used as decoctions for thousands
of years. However, from the aspect of advantage and convenience in preparation, portability and
sanitation, dry extract preparations such as granules or compactates, tablets and capsules have been
developed as alternative forms of dosage for decoctions. Decoction is still the most common form of
dosage in China, Korea, Australia and many other countries. However, exceptionally in Japan, nearly
100 % of the Kampo product market is taken up by dry extract preparations. Application of dry extract
preparations in other countries has increased in recent years and this is expected to continue.
Among the dry extract preparations mentioned above, granules and compactates are the most cost-
effective forms of dosage made by simple manufacturing procedures. Although granules are listed in
many pharmacopoeias as a major form of dosage, there is no standard specializing in granules made
from medicinal plants. In the manufacturing procedure of granules of medicinal plants, there are many
critical points to be taken into account. To obtain granules and compactates with consistent good
quality and without major processing troubles during manufacturing, these critical points must be
clarified and optimized prior to commercial production.
v
INTERNATIONAL STANDARD ISO 23419:2021(E)
Traditional Chinese medicine — General requirements
for manufacturing procedures and quality assurance of
granules
1 Scope
This document specifies general requirements for manufacturing procedures and quality and safety
assurance of granules and compactates made from traditional Chinese medicine extracts or powder
for oral use. This document excludes granules or compactates made from pure compounds (chemically
defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude
herbal and mineral drugs.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 19609-1, Traditional Chinese medicine — Quality and safety of raw materials and finished products
made with raw materials — Part 1: General requirements
ISO 19609-2, Traditional Chinese medicine — Quality and safety of raw materials and finished products
made with raw materials — Part 2: Identity testing of constituents of herbal origin
ISO 19617, Traditional Chinese medicine — General requirements for the manufacturing process of natural
products
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22467, Traditional Chinese medicine — Determination of microorganism in natural products
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia
medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
crude drug
medicinal part obtained from plants or animals, cell inclusions and secretions separated from the
origins, their extracts and minerals
[SOURCE: ISO 19617:2018, 3.8, modified — Notes to entry removed.]
3.2
critical parameter
parameter whose variability has an impact on quality and productivity of each product or
...