GB/T 28842-2021 English PDFUS$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 28842-2021: Operation specifications for medicinal product cold chain logistics Status: Valid GB/T 28842: Historical versions
Basic dataStandard ID: GB/T 28842-2021 (GB/T28842-2021)Description (Translated English): Operation specifications for medicinal product cold chain logistics Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A87 Word Count Estimation: 10,145 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 28842-2021: Operation specifications for medicinal product cold chain logistics---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.Operation specifications for medicinal product cold chain logistics ICS 03.220.01 CCSA87 National Standards of People's Republic of China Replace GB/T 28842-2012 Pharmaceutical cold chain logistics operation specifications Released on 2021-11-26 2022-06-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsForeword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 1 5 Personnel and training 1 6 Facilities and verification management 2 7 Temperature monitoring and control 2 8 Logistics operations 2 9 Emergency Management 3 10 Internal audit and improvement 3 Reference 5ForewordThis 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" Drafting. This document replaces GB/T 28842-2012 "Pharmaceutical Cold Chain Logistics Operation Specification", compared with GB/T 28842-2012, except for structural adjustments In addition to the overall and editorial changes, the main technical changes are as follows. a) The scope of application of Chapter 1 is changed (see Chapter 1, Chapter 1 of the.2012 edition); b) Deleted the definition of "refrigerated medicine" (2012 version 3.1), "cold place" (2012 version 3.2) and "frozen" (2012 version 3.3); Changed the definition of "pharmaceutical cold chain logistics" (see 3.1, 3.4 in.2012 edition); c) Added training requirements (see 4.1); changed facilities and equipment requirements (4.2, see 4.2 in the.2012 edition), temperature monitoring requirements (4.3, See the.2012 edition of 4.3); increase the quality document requirements (see 4.4); change the emergency requirements (4.5, see the.2012 edition of 4.4); Added internal audit requirements (see 4.6) and requirements for the retention period of records and vouchers (see 4.7); d) The personnel requirements (see 5.1,.2012 edition of 11.1), health inspection requirements (see 5.2,.2012 edition of 11.8), training plan Planning requirements (see 5.3,.2012 edition of 11.6), training content requirements (see 5.4,.2012 edition of 11.2, 11.3, 11.4, 11.5, 11.7); e) The corresponding requirements for facilities and equipment (see 6.1, 10.1 in the.2012 edition), verification requirements (see 6.2, 10.3 in the.2012 edition, and 10.5, 10.6), maintenance requirements for standby generator sets (see 6.3, 10.7 in the.2012 edition), relevant regulations for refrigerated trucks (see 6.4,.2012 10.4 of the annual edition); The relevant regulations for incubators (see 6.5), the same model and batch of refrigerated trucks, and the verification principles for refrigerated containers have been added (see 6.6); changed the verification document requirements (see 6.7, 10.8 in the.2012 edition); changed the alarm requirements (see 6.8, the.2012 edition 10.2); Deleted the contents of the archive record (see 10.9 in the.2012 edition); f) Added temperature deviation processing content (see 7.1); changed data archiving requirements (see 7.2,.2012 version 9.2); deleted temperature deviation Requirements for monitoring materials (see 9.1 in the.2012 edition), recording time requirements (see 9.3 in the.2012 edition), and alarm device requirements (see 2012 edition of 9.4), refrigeration equipment start and stop temperature setting requirements (see.2012 edition of 9.5), calibration requirements (see.2012 Version 9.6), temperature recording requirements (see.2012 version 9.7); g) The requirements for the receiving area have been changed (see 8.1.1, 5.1 in the.2012 edition); the protection requirements for the transfer of medicines to cold storage have been added (see 8.1.2); Changed the requirements for receiving goods (see 8.1.3, 5.2 and 5.3 of the.2012 edition); added the requirements for acceptance work (see 8.1.4); changed the return Drug handling requirements (see 8.1.5,.2012 edition of 5.4); delete receipt and acceptance record requirements (see.2012 edition of 5.5); h) The requirements for conservation plans and key conservation varieties have been added (see 8.2.1); the requirements for conservation treatment have been added (see 8.2.3); the differences have been changed. Common handling requirements (see 8.2.4,.2012 edition of 6.4); add unqualified drug handling requirements (see 8.2.5); delete drug stacks Stacking requirements (see 6.2 of the.2012 edition), color code management requirements (see 6.3 of the.2012 edition), maintenance record requirements (see the.2012 edition 6.5), recording equipment requirements (see 6.6 of the.2012 edition); i) The delivery requirements (see 8.3.1,.2012 version of 7.1, 8.1, 8.4), pre-cooling requirements (see 8.3.2,.2012 version 7.4), use Requirements for transportation with refrigerated trucks (see 8.3.3,.2012 version of 7.6, 7.8, 8.4, 8.5), requirements for transportation with refrigerated containers and incubators (see 8.3.4,.2012 version of 7.7, 8.2, 8.6, 8.7), over-temperature treatment requirements (see 8.3.5,.2012 version of 8.4); added Requirements for air transportation (see 8.3.6); The requirements for entrusting other units to transport drugs have been changed (see 8.3.7, 4.5 in the.2012 edition); deleted In addition to the requirements for stocking, dismantling, consolidation, packing, loading temperature (see 7.2 of the.2012 edition), delivery and loading area requirements (see.2012 Version 7.3), the signature requirements of the handover order before shipment (see 7.5 in the.2012 version); j) Emergency management requirements have been added (see Chapter 9); k) Internal audit and improvement requirements have been added (see Chapter 10); l) The informative Appendix A has been deleted (see Appendix A of the.2012 edition). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed and managed by the National Logistics Standardization Technical Committee (SAC/TC269). Drafting organizations of this document. China Federation of Logistics and Purchasing, Zhejiang Inte Logistics Co., Ltd., Songleng (Wuhan) Technology Co., Ltd., Beijing China Medical Union Enterprise Management Co., Ltd., Eli Lilly Trading Co., Ltd., Livzon Pharmaceutical Group Co., Ltd., Sinopharm Group Pharmaceutical Logistics Co., Ltd. Company, Shanghai Pharmaceutical Logistics Center Co., Ltd., China Resources Pharmaceutical Commercial Group Co., Ltd., Jointown Pharmaceutical Group Logistics Co., Ltd., Shanghai Pharmaceutical Branch Yuanxinhai Pharmaceutical Co., Ltd., Ruikang Pharmaceutical Group Co., Ltd., East China Ningbo Pharmaceutical Co., Ltd., Shaanxi Pharmaceutical Holding Group Paiang Medical Pharmaceutical Co., Ltd., Shaanxi Tasly Pharmaceutical Logistics Co., Ltd., Harbin Pharmaceutical Group Harbin Pharmaceutical Commercial Co., Ltd., Keyuan Xinhai (Beijing) Medical Supplies Trading Co., Ltd., Beijing Renfu Medical Equipment Co., Ltd., Jiangxi Wuzhou Pharmaceutical Marketing Co., Ltd., Beijing Shengshi Chinese Supply Chain Management Co., Ltd., Beijing Huaxin Logistics Co., Ltd., Shanghai Kangzhan Logistics Co., Ltd., SF Pharmaceutical Supply Chain Co., Ltd., Shanghai Shengsheng Logistics Co., Ltd., CIMC Cold Cloud (Beijing) Supply Chain Management Co., Ltd., Beijing Yingji Logistics Co., Ltd., Shanghai Tengyi Boshi International Freight Agency Co., Ltd., Shanghai Xinlian Road Logistics Co., Ltd., Qingdao Haier Biomedical Co., Ltd., Jiangsu Jingchuang Electric Co., Ltd. Co., Ltd., Zhongke Meiling Cryogenic Technology Co., Ltd., Panasonic Refrigeration System (Dalian) Co., Ltd., Hangzhou Zeda Instrument Co., Ltd., Hangzhou Lingshun Industrial Co., Ltd., Hangzhou Kelly Communication Co., Ltd., Guangdong Jianhai Cold Chain Co., Ltd., Jiangsu Elite Cooling and Heating Equipment Engineering Co., Ltd. Company, Zhejiang Xingxing Cold Chain Integration Co., Ltd., Hubei Jiuzhou Tongda Technology Development Co., Ltd., Polytech Genshu (Guangdong) Technology Co., Ltd. company. The main drafters of this document. Qin Yuming, Shao Yuejiong, Sun Lijun, Guo Wei, Zhu Xinyan, Xu Chao, Han Bing, Gu Yimin, Chen Ping, Yang Tao, Zhang Qingsong, Hou Liye, Zhang Bo, Lu Rui, Wang Yanan, Zhang Fang, Gao Lina, Chu Chenxi, Zeng Wei, Chen Moguang, Jia Guibin, Qin Jinna, Chen Guangyan, Wang Hao, He Qingwen, Liu Chaojun, Nabo, Zhang Kaiyi, Yu Songhai, Mei Yuqi, Liu Zhanjie, Li Chaofei, Qu Yaohui, Zhou Dan, Li Chengdong, Wang Wei, Zeng Jianqing, Lin Lin, Li Su, Li Zhengliang, Bai Hongxing, Zhang Daoguangyao, Chen Wei, Lu Ning, Li Qingwen, Wang Xiaoxiao, Liu Yang. The previous releases of this document and the replaced documents are as follows. ---In.2012, it was first published as GB/T 28842-2012; ---This is the first revision. Pharmaceutical cold chain logistics operation specifications1 ScopeThis document specifies the overall requirements for the pharmaceutical cold chain logistics process, personnel and training, facilities and equipment and verification management, temperature monitoring and control System, logistics operations, emergency management, internal audit and improvement. This document is applicable to drug cold chain logistics services and management.2 Normative referencesThe content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations 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 34399 Technical specification for verification performance confirmation of medical product cold chain logistics temperature control facility equipment WB/T 1097 General specification for cold chain incubators for medicines WB/T 1104 Functional configuration requirements for refrigerated trucks for road transportation of medical products3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Pharmaceutical cold chain logistics medicinalproductcoldchainlogistics Using special facilities and equipment, in accordance with the approved registration certificate and the temperature control requirements indicated in the instructions and labels, to ensure that the drug is produced In the process of use, the temperature is always controlled within the specified range of the logistics process.4 General requirements4.1 There should be suitable management and operation personnel, and the personnel should be trained accordingly. 4.2 There should be suitable temperature control facilities and equipment, and the facilities and equipment should be verified. 4.3 There should be a temperature monitoring system to monitor and record the temperature in the whole process of logistics operations, and the temperature data can be traced back. 4.4 The quality management system documents of drug cold chain logistics should be developed, and the operations should meet the requirements of Chapter 8. 4.5 An emergency management system should be developed and implemented. 4.6 An internal audit system should be established, and corresponding improvement measures should be formulated based on the conclusions. 4.7 All kinds of original records and vouchers in the process of drug cold chain logistics operations should be kept for at least 5 years, and the paper records should be clearly visible to prevent fading. Color, electronic data and records should be backed up off-site.5 Personnel and training5.1 A quality management department should be set up and equipped with full-time quality management personnel. 5.2 Pre-job and annual health inspections should be carried out for personnel who are in direct contact with drugs, and health records should be established. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 28842-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 28842-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 28842-2021_English with my colleagues?Answer: Yes. 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