GB/T 42282-2022 English PDF

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GB/T 42282-2022: General requirement for traditional Chinese medicine decocting center
Status: Valid

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Basic data

Standard ID: GB/T 42282-2022 (GB/T42282-2022)
Description (Translated English): General requirement for traditional Chinese medicine decocting center
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C90
Classification of International Standard: 11.120.30
Word Count Estimation: 7,770
Date of Issue: 2022-12-30
Date of Implementation: 2023-07-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 42282-2022: General requirement for traditional Chinese medicine decocting center

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.120.30 CCSC90 National Standards of People's Republic of China General requirements for decoction centers Posted on 2022-12-30 2023-07-01 implementation State Administration for Market Regulation Released by the National Standardization Management Committee

table of contents

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

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. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356). This document was drafted by. Beijing Donghuayuan Medical Equipment Co., Ltd., Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Capital Medical University Affiliated Beijing Hospital of Traditional Chinese Medicine, Shanghai Tongjitang Pharmaceutical Co., Ltd., Kangmei Pharmaceutical Co., Ltd., Jiuxin Traditional Chinese Medicine Co., Ltd., Zhejiang Intel Pharmaceutical and Medicinal Materials Co., Ltd., Tongjuntang Pharmaceutical Co., Ltd., Suzhou Tianling Chinese Herbal Pieces Co., Ltd., Shuguang Medical Affiliated to Shanghai University of Traditional Chinese Medicine Hospital, Shanghai SPH Huayu Pharmaceutical Co., Ltd., Nanjing Heling Pharmaceutical Service Co., Ltd., Wuhan Hospital of Traditional Chinese Medicine, Nanjing Canaan Zhongxinhe Medicine Department Technology Co., Ltd. The main drafters of this document. Jiang Libin, Yang Xinjian, Wu Jiankun, Huang Zhangxin, Ou Guoxiong, Zhu Zhiguo, Wang Shaohua, Shentu Yinhong, Xu Hongming, Liu Li, Song Yan, Zhang Yisheng, Zhang Liang, Nan Long, Yang Yuzhou, Fang Zheng, Tan Jing. General requirements for decoction centers

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 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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