ISO TS 5044-2023 PDF

Full title and description

Health informatics — Information model for quality control of traditional Chinese medicinal products. This ISO Technical Specification defines an information model and domain constraints intended to represent quality-control data and relationships used in the manufacturing and supervision of traditional Chinese medicinal (TCM) products.

Abstract

This technical specification specifies an information model representing the quality control of the manufacturing process of traditional Chinese medicinal products by defining a set of domain constraints for sanctioned characteristics and the relationships between them. It is intended to support data exchange, quality supervision and management across systems used in TCM manufacturing and regulatory oversight; Japanese Kampo medicine is explicitly outside the scope.

General information

• Status: Published.
• Publication date: June 2023 (Edition 1, published 2023-06).
• Publisher: International Organization for Standardization (ISO), developed under ISO/TC 215 (Health informatics).
• ICS / categories: 35.240.80 (Health informatics).
• Edition / version: Edition 1 (Technical Specification, 2023).
• Number of pages: 10.

Scope

The document applies to the representation of quality-control information for the manufacturing processes of Chinese materia medica and related traditional Chinese medicinal products. It covers an information model and constraints necessary to describe sanctioned characteristics and their relationships for quality supervision and management in manufacturing contexts. The specification does not cover Japanese Kampo medicine.

Key topics and requirements

• Information model for representing quality-control data for TCM manufacturing processes.
• Definition of domain constraints and sanctioned characteristics used in quality assessment and documentation.
• Specification of relationships between characteristics to support data integrity and interoperability.
• Support for quality supervision and management workflows in manufacturing and regulatory environments.
• Clear exclusion of Japanese Kampo medicine from the scope.
• Alignment with health informatics principles to facilitate system integration and data exchange.

Typical use and users

Intended users include health informatics specialists, IT implementers for pharmaceutical and herbal-medicinal manufacturers, quality assurance and regulatory personnel responsible for TCM product oversight, laboratory information managers, and standards developers working on interoperability and data models in the health products domain. The specification is used to design data models, exchange formats, and internal quality-control systems that need standardized representations of TCM manufacturing quality data.

Related standards

Related work is found within the ISO/TC 215 portfolio (health informatics) and other ISO standards addressing health data types, electronic health record interoperability and information models. Implementers commonly consider ISO technical work on health informatics data elements and exchange (for example, data-type and EHR-related specifications) when integrating the model into broader health information systems.

Keywords

health informatics, information model, quality control, traditional Chinese medicine, Chinese materia medica, domain constraints, TCM manufacturing, ISO/TS 5044:2023, interoperability.

FAQ

Q: What is this standard?

A: ISO/TS 5044:2023 is an ISO Technical Specification that defines an information model for quality control of traditional Chinese medicinal products, intended to standardize how quality characteristics and their relationships are represented for manufacturing and supervision purposes.

Q: What does it cover?

A: It covers an information model, domain constraints (sanctioned characteristics), and relationship definitions used to represent quality-control data in the manufacturing process of Chinese materia medica and TCM products. It supports data exchange and quality supervision but excludes Japanese Kampo medicine.

Q: Who typically uses it?

A: Typical users are health informatics professionals, system architects and implementers in pharmaceutical and herbal-medicine manufacturing, QA/QC and regulatory staff overseeing TCM products, and organizations integrating TCM quality data into electronic systems.

Q: Is it current or superseded?

A: As published in June 2023, ISO/TS 5044:2023 is the current Technical Specification (Edition 1). Users should check ISO or their national standards body for any later revisions or confirmations.

Q: Is it part of a series?

A: It is a Technical Specification developed under ISO/TC 215 (Health informatics) and should be considered alongside other ISO health informatics standards and technical specifications addressing data models, data elements and interoperability within the same domain.

Q: What are the key keywords?

A: Key keywords include health informatics, information model, quality control, traditional Chinese medicinal products, Chinese materia medica, domain constraints, and interoperability.