ISO 23963-1:2022

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.