ISO 23963-1:2022 PDF

Name: ISO 23963-1:2022 — Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components
SKU: ISO 23963-1:2022
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Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components

Название (английский):

ISO 23963-1:2022

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 7 июля 2022 г.
Издание:: ISO IS 23963 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO 23963-1:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications - who should use it

Related standards

Технические детали

ISO 18668-1:2016

Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding rules for Chinese medicin…

BS ISO 18668-2:2017

Coding system of Chinese medicines. Codes of decoction pieces.

BS ISO 18668-3:2017

Traditional Chinese medicine. Coding system for Chinese medicines. Codes for Chinese Materia Medica.

ISO 20333:2017

Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain management

ISO 22217:2020

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