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 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.
Open preview (PDF)Traditional Chinese medicine — Requirements for process traceability systems in Chinese materia medica and decoction pieces — Part 1: Components
