ISO 18977:2026 PDF

Overview

ISO 18977:2026 - Traditional Chinese medicine - Requirements for herbal dispensing services sets out internationally recognized standards for the safety and quality of herbal dispensing services in Traditional Chinese Medicine (TCM). The standard applies to large-scale herbal dispensaries, in-house hospital dispensaries, and medium to large commercial settings, providing a structured approach for facilities to manage herbal medicines efficiently and safely. Exclusions include medical clinics where dispensing occurs under the supervision of prescribing professionals, as well as specific requirements for tools and equipment. The goal is to ensure consistent quality, traceability, and risk management in herbal medicine dispensing operations, benefiting both service providers and patients.

Key Topics

• Facility and Environment Requirements

  • Proper organization of dispensing rooms, storage cabinets, and work areas
  • Environmental standards for temperature, humidity, cleanliness, and pest control
  • Sanitation and water quality requirements

• Personnel and Supervision

  • Mandated qualifications and responsibilities for supervisors and staff
  • Ongoing training and evaluation of employees
  • Health and hygiene protocols for staff

• Standard Operating Procedures (SOPs)

  • Comprehensive SOP documentation for all dispensing, sanitation, and material management activities
  • Regular review, revision, and approval processes
  • Maintenance and archiving of documentation for traceability

• Dispensing and Packaging Processes

  • Procedures for accurate, safe dispensing based on prescriptions or standardized in-pharmacy formulations
  • Detailed recordkeeping for each batch or dispensing unit
  • Packaging processes designed to prevent confusion and contamination

• Sanitation and Hygiene

  • Cleaning schedules, disinfection methods, and monitoring
  • Workers’ attire and health screenings
  • Strict prohibitions against food, smoking, or personal medication in work areas

• Material Receipt, Storage, and Inspection

  • Inspection and serial numbering of received herbs and materials
  • Segregated storage with first-in, first-out inventory control
  • Regular quality checks and documented disposal of expired or non-conforming materials

• Traceability and Self-Inspection

  • Systematic traceability using internal preparation numbers and documentation
  • Scheduled self-inspections and corrective actions to maintain compliance

Applications

ISO 18977:2026 is highly practical for a variety of settings in the TCM herbal medicine supply chain:

• Hospital and Institutional Dispensaries

  • Ensures safe, consistent preparation and dispensing of complex herbal prescriptions for inpatients and outpatients.

• Commercial Herbal Dispensaries

  • Enhances consumer confidence by guaranteeing quality assurance and traceability from receipt to final packaging.

• Supply Chain Management

  • Standardizes documentation and inventory workflows for raw materials, finished preparations, and subsidiary materials.

• Regulatory and Quality Compliance

  • Provides a framework to meet the requirements of national and international regulatory bodies for herbal medicine.
  • Simplifies audits and inspections through clear documentation and standardized procedures.

By following ISO 18977:2026, organizations can reduce errors and contamination risk, improve product quality, streamline staff training, and ensure regulatory compliance in herbal dispensing services.

Related Standards

• ISO 22217 - Traditional Chinese medicine - Storage requirements for raw materials and decoction pieces Provides detailed specifications for the proper storage conditions of herbal materials to maintain quality and safety.

• ISO 21371 - Traditional Chinese medicine - Labelling requirements of products intended for oral or topical use Establishes correct labelling protocols for herbal products, ensuring clarity and consumer safety.

• ISO 24512 - Drinking water quality - Guidelines for the management of drinking water utilities and drinking water services Ensures standards for water used in the dispensing and preparation process.

These related standards complement ISO 18977:2026 by addressing critical aspects of storage, labelling, and water quality essential for operating a safe and compliant herbal medicine dispensary.

Keywords: ISO 18977:2026, Traditional Chinese medicine, herbal dispensing, safety requirements, quality management, SOP, TCM dispensary, herbal medicine standards, traceability, sanitation, storage, labeling, training, compliance.