T/HNJK 03-2025 Technical Specifications for the Production of Traditional Chinese Medicine Pieces

Scope

This document stipulates the general principles of the processing standards for traditional Chinese medicine (TCM) slices; literature verification; nomenclature; processing methods and techniques; physical characteristics; identification; inspection; pharmacological properties and indications, usage and dosage; prescription preparation; precautions; storage; label printing; and requirements for the use of logos and certificates. This document applies to the preparation and formulation of TCM slices that are not yet included in national standards, but are documented in traditional Chinese medicine classics, or have established local processing characteristics and clinical usage traditions, or are listed in the appendices of national drug standards. TCM slices TCM slices are prescription drugs directly used in TCM clinical practice or preparation production after being processed and prepared according to TCM theories and processing methods. Directly orally administered TCM slices TCM slices that can be directly orally administered or dissolved without further processing. On-site processing of TCM slices at the production site TCM slices processed on-site using fresh TCM materials, excluding the initial processing of TCM materials at the production site. TCM slices processing standards Processing methods for locally used TCM slices not yet included in national drug standards. 4 General principles The entire production process and finished TCM slices shall comply with the requirements of the Pharmacopoeia of the People's Republic of China, GMP for TCM production, the Pharmaceutical Administration Law of the People's Republic of China, and the Implementing Regulations of the Pharmaceutical Administration Law of the People's Republic of China. Specialized crushing and granulation workshops and equipment shall be equipped. Collection of samples Samples of collected TCM materials shall be identified by experts in pharmaceutical botany, TCM

Development Information

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