ISO 23963-1:2022

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

General Information

• Status: Published
• Publication Date: 06-Jul-2022
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/JWG 1 - Joint ISO/TC 249 - ISO/TC 215 WG: Informatics
• Parallel Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 07-Jul-2022
• Due Date: 18-Mar-2022
• Completion Date: 07-Jul-2022

Overview

ISO 23963-1:2022 specifies requirements for process traceability systems applied to Traditional Chinese Medicine (TCM) raw materials - Chinese materia medica - and decoction pieces. As Part 1: Components, the standard defines the information checkpoints, recordkeeping and procedural elements needed to trace products through planting/breeding, circulation, manufacturing, processing and clinical or production use. The aim is to improve supply chain transparency, product quality and safety across the TCM sector.

Key topics and technical requirements

• Scope and definitions: clear definitions for traceability, traceability system, Chinese materia medica and decoction pieces to ensure consistent implementation.
• Basic vs extended traceability information: mandatory minimum data (e.g., production site, lot numbers, receiving/dispatch records) plus optional extended data (e.g., certifications, area codes, qualification records).
• Four standardized identifiers: products, stakeholders, production subsets (manufacturing/production units) and locations - all required for accurate tracking.
• Procedures and documentation:
  • Organizations must develop procedure documents covering system roles, traceability procedures for key process links and review procedures.
  • Records may be electronic or paper; responsible persons and record keepers must be identified.
• Archiving and retention: all traceability records must be retained; the standard requires keeping records at least one year after expiry, end of use or other end-of-chain events.
• Traceability checkpoints: detailed information to be recorded for:
  • Planting/breeding (enterprise, base qualifications, seed sources, planting practices)
  • Use of agrochemicals and disinfectants (product, batch, user qualifications)
  • Harvesting (dates, methods, environmental factors)
  • Post-harvest processing, transportation and warehousing
  • Receiving, circulation and use of decoction pieces
• Quality inspection: recording inspection reports and certificates of analysis as part of traceability data.

Applications - who should use it

• TCM manufacturers and decoction-piece processors implementing supply chain traceability
• Agricultural producers and GAP-certified planting bases supplying Chinese materia medica
• Distributors, wholesalers, and pharmacists handling decoction pieces
• Quality assurance, regulatory bodies and certification organizations assessing compliance
• IT vendors and system integrators building traceability software for TCM supply chains

Related standards

• ISO 18668-1 / ISO 18668-2 / ISO 18668-3 (linked TCM information and quality standards)
• ISO 20333 (relevant data standards)
• ISO 22217 (storage requirements for raw materials and decoction pieces)

ISO 23963-1:2022 is a practical baseline for implementing robust process traceability systems in the TCM supply chain, helping organizations meet regulatory expectations, enhance product safety and support internationalization of Traditional Chinese Medicine.

Standards Content (Sample)

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 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.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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 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
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.
iv
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.
v
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.]
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.
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
...