Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components

This document specifies the requirements for process traceability systems in Chinese materia medica and decoction pieces, including checkpoints of traceability information about the planting or breeding and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of decoction pieces.

Médecine traditionnelle chinoise — Exigences relatives au système de traçabilité du processus pour la Materia Medica chinoise et les décoctions — Partie 1: Composants

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Status
Published
Publication Date
06-Jul-2022
Current Stage
6060 - International Standard published
Due Date
18-Mar-2022
Completion Date
07-Jul-2022
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ISO 23963-1:2022 - Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components Released:7. 07. 2022
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INTERNATIONAL ISO
STANDARD 23963-1
First edition
2022-07
Traditional Chinese medicine —
Requirements for process traceability
systems in Chinese materia medica
and decoction pieces —
Part 1:
Components
Médecine traditionnelle chinoise — Exigences relatives au système
de traçabilité du processus pour la Materia Medica chinoise et les
décoctions —
Partie 1: Composants
Reference number
ISO 23963-1:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 23963-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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.
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Email: copyright@iso.org
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Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 23963-1:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Traceability requirements ........................................................................................................................................................................2

4.1 Basic requirements ............................................................................................................................................................................. 2

4.2 Requirements for traceability procedures and archives .................................................................................. 3

4.2.1 Documents ............................................................................................................................................................................... 3

4.2.2 Archives ...................................................................................................................................................................................... 3

4.3 Requirements for traceability information .................................................................................................................. 3

4.3.1 General ........................................................................................................................................................................................ 3

4.3.2 Traceability information regarding planting and breeding ........................................................ 4

4.3.3 Traceability information regarding the quality inspection of Chinese

materia medica .................................................................................................................................................................... 5

4.3.4 Traceability information regarding the circulation of Chinese materia

medica .......................................................................................................................................................................................... 5

4.3.5 Traceability information regarding decoction piece processing ............................................ 6

4.3.6 Traceability information regarding the use of entities of decoction pieces .................. 7

Bibliography ................................................................................................................................................................................................................................ 9

iii
© ISO 2022 – All rights reserved
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ISO 23963-1:2022(E)
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.

A list of all parts in the ISO 23963 series can be found on the ISO website.

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.
© ISO 2022 – All rights reserved
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ISO 23963-1:2022(E)
Introduction

Chinese medicine (medicinal plants, animals and minerals) originates from a wide variety of different

sources of supply. The production documentation is handled differently by each company and important

manufacturing steps are usually not fully documented. Several companies are usually involved in the

manufacturing process of Chinese medicine and relevant information is often not passed on fully from

one company to the other. This makes it very difficult for manufacturers and consumers to retrace the

entire production process (e.g. cultivation, harvesting, processing, storage and logistics) and to assess

the quality and safety of Chinese medicine. The lack of transparency in the manufacturing process

slows down to a certain extent the further development and internationalization of traditional Chinese

medicine. Therefore, a supply chain traceability system is needed which ensures that the documentation

of all product-relevant information is standardized and available at all times. Such a system will enable

companies to better evaluate their suppliers and to convince end users of the quality and safety of their

products.

This document is consistent with ISO 18668-1, ISO 18668-2, ISO 18668-3 and ISO 20333. It includes the

application of these documents and provides a solution to improve the management of all processes

related to Chinese medicine, contributes to the establishment of the traditional Chinese medicine

supply chain traceability system and quality-investigating mechanism, enhances product quality and

competitiveness, protects consumers' rights and ensures safe and effective application in clinical use.

This document can promote the process of standardization, informatization and modernization for

traditional Chinese medicine.
© ISO 2022 – All rights reserved
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INTERNATIONAL STANDARD ISO 23963-1:2022(E)
Traditional Chinese medicine — Requirements for process
traceability systems in Chinese materia medica and
decoction pieces —
Part 1:
Components
1 Scope

This document specifies the requirements for process traceability systems in Chinese materia medica

and decoction pieces, including checkpoints of traceability information about the planting or breeding

and circulation of Chinese materia medica, and the manufacturing, processing and use of entities of

decoction pieces.
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 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces

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
traceability

ability to track Chinese materia medica and decoction pieces forward through specified stages of

planting or breeding, manufacturing, processing, circulation, transport, storage and usage

3.2
traceability system

manual or electronic system that provides the ability to access any or all information relating to the

material or product under consideration throughout their life cycle, by means of accessing documented

information
3.3
Chinese materia medica

medicinal parts of medicinal plants, animals and minerals after preliminary processing, which are used

as raw materials in Chinese medicines
Note 1 to entry: This refers to the raw materials used to make decoction pieces.
[SOURCE: ISO 18668-1:2016, 3.2, modified — abbreviated term CMM removed.]
© ISO 2022 – All rights reserved
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ISO 23963-1:2022(E)
3.4
decoction piece

prescription medicinal processed from Chinese materia medica under the direction of traditional

Chinese medicine and processing methods for Chinese medicines, which can be directly used in clinical

practice or the production of prepared medicines

[SOURCE: ISO 18668-1:2016, 3.3, modified — definition revised and note to entry removed.]

3.5
basic traceability information

minimum information that enables an item or product to be traced and tracked inside or outside of the

organization

EXAMPLE Places of production, manufacturing enterprises and lot numbers of products.

3.6
extended traceability information
information relating to product quality, safety and other commercial purposes
EXAMPLE Qualification certification, codes and area.
3.7
inspection report

quality control documents (certificate of analysis) provided by third-party organizations regarding the

inspection of each batch of Chinese materia medica
3.8
warehouse-in
storage of incoming qualified Chinese materia medica in a warehouse

Note 1 to entry: Storage shall be in accordance with the requirements of ISO 22217.

3.9
warehouse-out
removal of the qualified Chinese materia medica from a warehouse

Note 1 to entry: Handling of outgoing goods shall be in accordance with the requirements of ISO 22217.

4 Traceability requirements
4.1 Basic requirements

4.1.1 Process traceability systems enable transmission of information from upstream suppliers to

downstream users.

4.1.2 Recorded information of products is divided into basic traceability information, which shall be

recorded, and extended traceability information, which is recorded as necessary.

4.1.3 Organizations that establish a traceability system according to this document shall identify and

confirm their role and position in the links of planting or breeding, circulation, processing and use of

Chinese medicines in order to determine the traceability point.

4.1.4 Relevant traceability information regarding entities of the planting or breeding and circulation

of Chinese materia medica and the processing and use of decoction pieces shall be recorded.

© ISO 2022 – All rights reserved
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ISO 23963-1:2022(E)

4.1.5 To successfully trace products through a supply chain, it is necessary to identify the following

four key elements in a standardized way:
i) products;
ii) stakeholders;
iii) subsets of products based on manufacturing or production;
iv) locations.

This should start with the master data unambiguously identifying products, distinguishing between

them by name, index ingredient, strength, pharmaceutical form, packaging and often their pre-

established market destination. Medicines need to be identified at the saleable package level (sometimes

referred to as the lowest level of packaging for sale to a pharmacy or patient).

The number of uniquely identified manufacturing or production units conversely determines the

accuracy of possible tracking and tracing.

Locations and all parties involved shall be clearly identifiable so that product movements between

owners and/or locations can be documented in the traceability system.
4.2 Requirements for traceability procedures and archives
4.2.1 Documents

4.2.1.1 The organization shall develop procedure documents to specify the requirements and

implement procedures of the traceability system.

4.2.1.2 The organization shall establish procedural documents for the traceability system, including

at least the following information:
a) organization structure, obligations and rights of the traceability system;

b) traceability procedures of key links in the process from source material to the delivery of final

products;
c) review procedure.
4.2.2 Archives

4.2.2.1 The organization shall record the necessary data for all links of the traceability procedure by

electronic or paper documents and identify the responsible person and keeper of these records.

4.2.2.2 The organization shal
...

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