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GB/T 42282-2022Gerneral requirement for traditional Chinese medicine decocting center (English PDF)

煎药中心通用要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

July 1, 2023

Scope

GB/T 42282-2022 is the English-translated version of 煎药中心通用要求.

GB/T 42282-2022 is the Chinese national standard of general requirements for a traditional Chinese medicine decocting centre, the facility that prepares prescribed decoctions.

Its requirements clause follows the work in order - receiving and reviewing the prescription, dispensing, soaking, decocting, packaging, distribution and delivery, and information management - and a further clause covers sanitation and safety.

The general requirements have the centre equipped with decocting, decoction-packaging, dispensing and computer equipment, with the decocting machine meeting GB/T 30219 and the packing machine meeting JB/T 20116, and have decoction pieces kept in ambient, shaded or low-temperature stores built against damp and heat rather than in the open air.

Clause 1 applies the document to the process and management of such centres. Issued on 30 December 2022, applicable since 1 July 2023.

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Document preview — GB/T 42282-2022

National Standard of the People's Republic of China

ICS: 11.120.30
Classification: C 90

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 General requirements
5 requirements
5.1 Receiving Party and Reviewing Party
5.2 Adjustment
5.3 Soak
5.4 Decoction
5.5 Packaging
5.6 Drug distribution and delivery
5.7 Information Management
6 Health and Safety
6.1 Sanitation
6.2 Security

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting.

1 Scope

This document specifies the requirements, hygiene and safety of the decoction center.

This document is applicable to the process and management of the decoction center.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 10004-2008 Plastic lamination film for packaging, bag dry lamination, extrusion lamination

GB/T 30219 Traditional Chinese medicine decoction machine

GB/T 36030 General Technical Requirements for Cleaning in Place and Sterilization of Pharmaceutical Machinery (Equipment)

GB/T 36035 General Requirements for Electrical Safety of Pharmaceutical Machinery

JB/T 20116 Traditional Chinese Medicine Decoction Packing Machine

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 decoction center

Based on the theory of decoction of traditional Chinese medicine, modern technologies such as the Internet are used to meet the personalized customization of the decoction system.

4 General requirements

4.1 Internal and external use and special drugs should be equipped with equipment according to prescription requirements.

4.2 The decoction center should be equipped with traditional Chinese medicine decoction equipment, traditional Chinese medicine decoction packaging equipment, dispensing equipment, computer equipment and corresponding environment.

4.3 The traditional Chinese medicine decoction machine shall meet the requirements of GB/T 30219.

4.4 The traditional Chinese medicine decoction packaging machine shall meet the requirements of JB/T 20116.

4.5 The storage of Chinese medicinal decoction pieces should be stored in warehouses such as normal temperature warehouse, shade warehouse, and low temperature warehouse for traditional Chinese medicinal materials according to the characteristics of the decoction pieces.

It should be stored in the open air, and the warehouse floor and walls should have moisture-proof, heat insulation, ventilation and other facilities and technical measures.

5 Requirements

5.1 Receiving party and reviewing party

5.1.1 Receiver

5.1.1.1 The prescription management of the decoction center should include prescription access and prescription inquiry. It should be able to realize the input, transmission and query of prescription information.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 47606-2026|GB/T 15692-2024|GB/T 44036-2024|GB/T 42354-2023|GB/Z 42344-2023|GB/Z 42540-2023

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