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RB/T 071-2021: General requirements for evaluation of genuine regional materia medica
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RB/T 071-2021: General requirements for evaluation of genuine regional materia medica

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General requirements for evaluation of genuine regional materia medica ICS 03.120.20 CCSA00 People's Republic of China Certification and Accreditation Industry Standards General requirements for the evaluation of authentic medicinal materials Published on 2021-11-04 2022-01-01 Implementation Released by the National Certification and Accreditation Administration of the People's Republic of China

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 of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the National Certification and Accreditation Administration. This document is drafted by. Zhongjian'an Testing and Certification Center Co., Ltd., Institute of Medicinal Plants, Chinese Academy of Medical Sciences, China Science of Traditional Chinese Medicine Institute of Traditional Chinese Medicine Resource Center, China Traditional Chinese Medicine Association Traditional Chinese Medicine Testing and Certification Technology Professional Committee, State Administration for Market Regulation Certification and Accreditation Technology Research Center, Chengdu University of Traditional Chinese Medicine, Sichuan Academy of Traditional Chinese Medicine, Beijing University of Traditional Chinese Medicine, China Merchants Health Industry (Qichun) Co., Ltd., Guangzhou Xiangxue Pharmaceutical Co., Ltd., Dong'e Ejiao Co., Ltd., Tasly Holding Group Co., Ltd., Yunnan Baiyao Group Co., Ltd. Co., Ltd., Kangmei Xinkaihe (Jilin) Pharmaceutical Co., Ltd., China Beijing Tongrentang (Group) Co., Ltd., Zhejiang Shouxiangu Medical Co., Ltd. Pharmaceutical Co., Ltd., Tianfangjian (China) Pharmaceutical Co., Ltd., Yunnan Sanqi Technology Co., Ltd., Inner Mongolia Hongkui Biological Pharmaceutical Co., Ltd., Beijing Zhongyan Baicao Testing and Certification Co., Ltd. The main drafters of this document. Hu Shilin, Zhang Bengang, Guo Lanping, Yang Zehui, Gao Weiwei, Qi Yaodong, Zhan Zhilai, Sun Xiaobo, Deng Bin, Xiao Xiaohe, Peng Cheng, He Yali, Zhao Junning, Liu Chunsheng, Feng Jia, Wang Guihua, Guo Jinlin, Yuan Guiping, Ma Huanhao, Li Xuejun, Li Mingyan, Wang Yonghui, Zhou Xiangshan, Yan Xijun, Su Bao, Xin Wenfeng, Du Dan, Tian Ruihua, Zeng Yuan, Tian Menghua, Guo Ailing, Nie Zhengbao.

Introduction

Daodi medicinal materials are recognized as high-quality medicinal materials since ancient times, and are one of the most characteristic cores of traditional Chinese medicine in the field of traditional Chinese medicine resources. precious cultural heritage. Carrying out authentic medicinal materials certification will help standardize the production management of authentic medicinal materials and protect the cultural value and brand of authentic medicinal materials Value, which is an important means to ensure the quality of authentic medicinal materials and promote the sustainable use of authentic medicinal materials. To formulate general requirements for the evaluation of authentic medicinal materials, Not only will it help standardize the certification service process and improve work efficiency, it will also enhance the market competitiveness of certified companies and greatly improve the quality of authentic medicinal materials. Brand influence is of great significance to the implementation of authentic medicinal materials certification. According to the definition of "authentic medicinal materials" in the Law of the People's Republic of China on Traditional Chinese Medicine, this document takes the quality characteristics of authentic medicinal materials as the core, and fully considers the quality characteristics of authentic medicinal materials. Consideration of the source of medicinal materials, historical evolution, habitat characteristics and environmental safety requirements of authentic regions, production and processing and other quality characteristics of authentic medicinal materials. Qualitative factors, focus on the inheritance and safety of authentic medicinal materials, and formulate general requirements for the evaluation of authentic medicinal materials. General requirements for the evaluation of authentic medicinal materials

1 Scope

This document specifies the general requirements for the evaluation of authentic medicinal materials of plant, animal, fungal and mineral origin, including general rules, evaluation content, evaluation Report and result judgment. This document is applicable to the evaluation of authentic medicinal materials by third-party certification bodies, and can also be referred to by Daodi medicinal material production organizations and other relevant institutions. use.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB 3095 Ambient Air Quality Standard GB 5084 Farmland Irrigation Water Quality Standard GB 5749 Hygienic Standard for Drinking Water GB 15618-2018 Soil Environmental Quality Agricultural Land Soil Pollution Risk Control Standard (Trial) GB 18596 Pollutant discharge standard for livestock and poultry breeding industry SB/T 11094 Standard for the management of storage of Chinese medicinal materials SB/T 11095 Technical Specifications for Warehouses of Chinese Herbal Medicines SB/T 11182 Technical Specification for Packaging of Chinese Medicinal Materials "Pharmacopoeia of the People's Republic of China" "Quality Management Standard for Production of Chinese Medicinal Materials (Trial)"

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 The raw materials of traditional Chinese medicine decoction pieces formed by removing non-medicinal parts from plants, animals, animal and plant secretions, fungi and minerals that meet the drug standards. 3.2 After long-term clinical application of traditional Chinese medicine, it is produced in a specific area. Compared with the same kind of Chinese herbal medicine produced in other areas, its quality and curative effect are better. Better, and stable quality, Chinese herbal medicines with high reputation. Note 1."Long-term clinical application of traditional Chinese medicine" and "high popularity" in the definition refer to clear historical records and widely recognized in the industry. Note 2.In the definition, "compared with the same kind of Chinese medicinal materials produced in other regions, the quality and curative effect are better, and the quality is stable" in the definition is embodied in this document. Local area, origin, specific production and processing methods, traits and clinical efficacy. Note 3.From the "Chinese Medicine Law of the People's Republic of China", the definition of "authentic medicinal materials". ...