Overview
ISO/TS 5044:2023 - Health informatics - Information model for quality control of traditional Chinese medicinal products - defines an information model for the quality control of the manufacturing process of traditional Chinese medicinal products (Chinese materia medica). Published as a Technical Specification in 2023, the document specifies domain constraints made up of sanctioned characteristics and their relationships, to support consistent description, supervision and management of production quality. Japanese KAMPO medicine is excluded from the scope.
Key topics and technical requirements
- Information model structure: graphical and textual representation of entities and their relationships (concepts, categories, characteristics).
- Domain constraints: sanctioned characteristics used to represent quality attributes and process controls; each characteristic is composed of one or more defined relationships.
- Semantic links (relationship types): standardized directed relations used in the model, including measure, consist of, characterize, affect, be processed into, have attribute of, include, and evaluate.
- Characterizing categories: defined testing and quality dimensions relevant to Chinese materia medica, e.g. chemical analysis, bioanalysis, character analysis, impurities, effective constituents, endogenous/exogenous toxic components, heavy metals, pesticide residue, microbiological detection, fingerprint (chromatogram), moisture/ash/residual solvent/pH.
- Manufacturing context: links quality attributes with production concepts such as formula, prescription dosage, production, equipment, critical process parameters, adjuvant material, and other process metadata to enable traceable quality supervision.
- Terminology governance: clarifies terms and definitions to reduce ambiguity across jurisdictions and support interoperable data exchange.
Applications and who uses it
ISO/TS 5044 is designed for organizations involved in the manufacture, testing, regulation and informatics of traditional Chinese medicinal products:
- Manufacturers - to model and document critical quality attributes (CQAs) and critical process parameters (CPPs) across production workflows.
- Quality assurance & regulatory authorities - to standardize supervision, inspections and cross-border quality assessment.
- Analytical laboratories - to align test descriptors (fingerprints, HPLC, MS, microbiology) with manufacturing records.
- Health informatics and standards teams - to implement interoperable data models that support quality management systems and reporting.
Related standards
Standards referenced or aligned in the text include ISO/IEC 19763-12, ISO 18668-1, ISO 11238, ISO 15206 and ISO 17115. Implementers should review these for terminology, data-modeling and regulatory mapping.
Keywords: ISO/TS 5044, health informatics, information model, quality control, traditional Chinese medicinal products, Chinese materia medica, manufacturing quality, semantic links.