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GB/T 30335-2023 English PDF

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Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 30335-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$248.00 · In stock
Delivery: <= 2 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 30335-2023: Specification for logistics service of medicinal product
Status: Valid

GB/T 30335: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 30335-2023	248	Add to Cart	2 days	Specification for logistics service of medicinal product	Valid
GB/T 30335-2013	359	Add to Cart	3 days	Service specification of drug logistic	Obsolete

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Basic data

Standard ID: GB/T 30335-2023 (GB/T30335-2023)
Description (Translated English): Specification for logistics service of medicinal product
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A80
Classification of International Standard: 03.220
Word Count Estimation: 14,140
Date of Issue: 2023-09-07
Date of Implementation: 2023-09-07
Older Standard (superseded by this standard): GB/T 30335-2013
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 30335-2023: Specification for logistics service of medicinal product

---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 03.220 CCSA80 National Standards of People's Republic of China Replace GB/T 30335-2013 Pharmaceutical logistics service specifications Published on 2023-09-07 Implemented on 2023-09-07 State Administration for Market Regulation Released by the National Standardization Administration Committee

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces GB/T 30335-2013 "Pharmaceutical Logistics Service Specifications". Compared with GB/T 30335-2013, except for structural adjustment and In addition to editorial changes, the main technical changes are as follows. a) Added scope of inapplicability (see Chapter 1); b) Delete the definition of pharmaceutical logistics (see 3.1 of the.2013 version); c) Changed the facility and equipment requirements (see 4.5, 4.2 of the.2013 version), deleted specially managed drugs and national special management requirements Logistics service requirements for pharmaceuticals (see 4.3 of the.2013 version), management system requirements (see 4.1), and operational process requirements (see 4.2), emergency plan requirements (see 4.3); d) Added personnel and training requirements (see Chapter 5); e) Added facility and equipment requirements (see Chapter 6); f) Added information system requirements (see Chapter 7); g) The review requirements for inbound and outbound warehouses (see 8.1.1, 5.1.1 of the.2013 edition) and the preparation requirements for inbound and outbound warehouses (see 8.1.2,.2013 edition of 5.1.2), added requirements for additional materials entering and exiting the warehouse (see 8.1.3); h) Changed the requirements for acceptance (see 8.2.3, 5.2.1 of the.2013 version) and the requirements for acceptance of refrigerated and frozen drugs (see 8.2.5, 5.2.2 of the.2013 edition), the requirements for acceptance items are deleted (see 5.2.3 of the.2013 edition), and the requirements for the receiving site are added requirements (see 8.2.1), requirements for the area to be inspected (see 8.2.2), and handling requirements for sampling and accepting problematic drugs (see 8.2.4); i) The requirements for handling and loading have been deleted (see 5.3.1 of the.2013 edition), and the requirements for drug stacking have been changed (see 8.3.1,.2013 edition of 5.3.2), drug temperature and humidity storage requirements (see 8.3.2, 5.3.3 of the.2013 edition), color standard management requirements (see 8.3.3,.2013 edition 5.3.4 of the.2013 version), deleted the requirements for protective measures for drug storage (see 5.3.5 of the.2013 version), and changed the drug maintenance requirements (see.2013 version of 5.3.5). 8.3.4, 5.3.6 of the.2013 version), deleted the requirement for drug loss (see 5.3.8 of the.2013 version), and added the requirement for drug accidents Requirements for safe handling (see 8.3.6), requirements for personnel working in storage areas (see 8.3.7), and storage and maintenance of refrigerated and frozen medicines requirements (see 8.3.8); j) The requirements for reviewing vehicle information when drugs are shipped out of the warehouse have been changed (see 8.4.1, 5.4.1 in the.2013 version), and the additional information on drugs shipped out of the warehouse has been deleted. requirements for materials (see 5.4.2 of the.2013 edition), and changed the requirements for dismantling and consolidating shipments of medicines (see 8.4.2, the.2013 edition of 5.4.3), description requirements for drugs requiring temperature control (see 8.4.3, 5.4.4 of the.2013 version); k) Changed the requirements for handling of returned drugs after sale (see 8.5.1, 5.5.1 of the.2013 version) and the description requirements for drugs that require temperature control (see 8.5.3,.2013 version 5.5.3); l) Changed the handling requirements for problematic drugs (see 8.6.1, 5.6.1 of the.2013 version), and the objects for confirming unqualified drugs (see 8.6.2, 5.6.2 of the.2013 version), added requirements for the handling of medicines in the event of cargo damage or cargo difference (see 8.6.3); m) Changed the content of data requirements (see 8.7.1, 5.7.1 of the.2013 version); n) Delete the requirements for environmental temperature and humidity control of pharmaceutical warehouses (see 5.8 of the.2013 version); o) Changed warehouse and cargo location identification descriptions and reference standard requirements (see 8.8.2, 5.9.2 of the.2013 version); p) Changed the measures for transporting drugs (see 9.1, 6.1 of the.2013 version) and the transportation and distribution requirements for refrigerated and frozen drugs (see 9.6, 6.2 of the.2013 edition), requirements for information verification before transportation (see 9.2, 6.3 of the.2013 edition), and what to do if the vehicle fails to operate normally. handling requirements (see 9.4, 6.5 of the.2013 version), and added requirements for entrusted transportation (see 9.5); q) The requirements for lost or damaged medicines are deleted (see 7.4 of the.2013 edition), and the requirements for loading, unloading and transportation of refrigerated and frozen medicines are added. (see 10.4); r) Changed the description requirements for handover (see Chapter 11, Chapter 8 of the.2013 edition) and the description requirements for drugs requiring temperature control (see 11.4,.2013 version 8.3); s) Added requirements for value-added services (see Chapter 12); t) Changed the description requirements for information services (see Chapter 13, Chapter 9 of the.2013 edition) and deleted the requirements for information management (see the.2013 9.1 of the.2013 version), logistics information service requirements with temperature control requirements (see 9.2 of the.2013 version), and added requirements for information system drills (See 13.1), traceability requirements (see 13.2), data backup requirements (see 13.3); u) The requirements for describing risk control have been changed (see Chapter 14, Chapter 10 of the.2013 edition), and the requirements for safety management systems have been deleted (see 10.1 of the.2013 edition), emergency plan requirements (see 10.2 of the.2013 edition), insurance requirements (see 10.3 of the.2013 edition), entrustment requirements (see 10.4 of the.2013 edition), data backup requirements (see 10.5 of the.2013 edition), and added requirements for warehouse equipment and monitoring (see 14.1), facility and equipment management requirements (see 14.2), vehicle safety management requirements (see 14.3), specially managed drugs and national There are special management requirements for handling stolen, robbed, and lost medicines (see 14.4); v) Changed the requirements for complaint objects (see 15.1, 11.1 of the.2013 version) and the description requirements for complaint handling (see 15.2,.2013 version of 11.2); w) Added requirements for service evaluation and improvement (see Chapter 16); x) The requirements for expressing the main evaluation indicators of service quality have been changed (see Appendix A, Chapter 12 of the.2013 version), and the accuracy of acceptance has been deleted. rate (see 12.1 of the.2013 version), the requirements for on-time rate of outbound order completion (see A.3), cargo difference rate (see A.6), Customer satisfaction requirements (see A.8). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed and coordinated by the National Logistics Standardization Technical Committee (SAC/TC269). This document was drafted by. China Federation of Logistics and Purchasing, Sinopharm Pharmaceutical Logistics Co., Ltd., China Railway Express Co., Ltd., Li Lai Trading Co., Ltd., Fujian New World Automatic Identification Technology Co., Ltd., Beijing Kexing Biological Products Co., Ltd., Guangzhou Jinyu Medical Testing Group Co., Ltd., Bayer Healthcare Co., Ltd., Zhejiang Inte Logistics Co., Ltd., Zhejiang Jinyu Automobile Manufacturing Co., Ltd., Livzon Pharmaceutical Group Co., Ltd., Shanghai Roche Pharmaceutical Co., Ltd., Qilu Pharmaceutical Group Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd., Borui Biopharmaceutical (Suzhou) Co., Ltd., Shanghai Pharmaceuticals Holdings Co., Ltd., China Resources Pharmaceutical Commercial Group Co., Ltd., Jiuzhoutong Pharmaceutical Group Logistics Co., Ltd., Guangzhou Pharmaceutical Co., Ltd., Nanjing Pharmaceutical Co., Ltd., Chuangmei Pharmaceutical Co., Ltd., Shanghai Pharmaceutical Science Park Xinhai Pharmaceutical Co., Ltd., Sinopharm Logistics Co., Ltd., Qingdao Baiyang Pharmaceutical Co., Ltd., Jiangsu Pharmaceutical Co., Ltd., Anhui Tianxing Medical Pharmaceutical Group Co., Ltd., Guangdong General Pharmaceutical Co., Ltd., Hunan Pharmaceutical Group Co., Ltd., Hunan Dajia Weikang Pharmaceutical Co., Ltd., Jiangxi Wu Zhou Pharmaceutical Marketing Co., Ltd., General Technology Henan Pharmaceutical Co., Ltd., Hunan Tianrun Biopharmaceutical Co., Ltd., Jixiang Water (Shandong) Pharmaceutical Logistics Co., Ltd., SF Pharmaceutical Supply Chain Co., Ltd., Beijing Shengshi Chinese Supply Chain Management Co., Ltd., Shanghai Kangzhan Logistics Co., Ltd. Company, Shanghai Biomass Logistics Co., Ltd., Shandong Dashun Pharmaceutical Logistics Co., Ltd., Beijing Yingji Pharmaceutical Cold Chain Technology Co., Ltd., Shanghai Tengyi Boshi International Freight Forwarding Co., Ltd., China Postal Express Logistics Co., Ltd., Chengdu Yisu Logistics Co., Ltd., Zhongjian Yunchang (Guangzhou) Logistics Supply Chain Co., Ltd., Zhejiang Dean Deep Sea Cold Chain Logistics Co., Ltd., Guangzhou Jinyida Logistics Co., Ltd., Shandong Jian'an Pharmaceutical Transportation Supply Chain Co., Ltd., Shanghai Kaili Transportation Air Conditioning Equipment Co., Ltd., Hubei Kailishi Tongda Technology Co., Ltd., Chunjun New Materials (Shenzhen Shenzhen) Co., Ltd., Qingdao Haier Biomedical Co., Ltd., Shenzhen Zhousi Mobile Internet of Things Technology Co., Ltd., Science and Technology Genshu (Guangdong) Technology Co., Ltd., Shenzhen Senruo New Material Technology Co., Ltd., and Beijing Megvi Robot Technology Co., Ltd. The main drafters of this document. Qin Yuming, Zhao Lidong, Hu Wei, Wang Xiaoxiao, Xu Chao, Guo Dong, Li Jing, Chen Bingyi, Guo Wei, Wu Jinghai, Cao Qian, Ren Gang, Zhang Qingsong, Shao Yuejiong, Shao Mingfu, Zhang Ying, Han Bing, Wang Wei, Luo Qiyao, He Li, Huang Yangqing, Zhang Shiyuan, Liang Jin, Peng Qixing, Fan Jidong, Lin Zhijie, Hou Liye, Xu Ke, Zhu Chengjun, Yuan Jing, Ni Huaan, Lin Weifang, Chen Rongbo, Wen Fang, Li Qi, Zhang Li, Wang Danjie, Miao Yongming, Gao Wei, Liu Weimin, Qin Jinna, Wang Hao, Liu Chaojun, Kang Juan, Wang Zhiyuan, Ding Yanli, Huang Haiteng, Zeng Xiaolan, Yang Yanjun, Ding Liping, Liu Tianyu, Gao Ge, Bai Hongxing, Li Jian, Liu Zhanjie, Cai Xudong, Zhang Daoguangyao, Yang Ruohan, Xu Qingcai, Xie Yuanxun, Liu Yang. The previous versions of the documents replaced by this document are as follows. ---First published as GB/T 30335-2013 in.2013; ---This is the first revision. Pharmaceutical logistics service specifications

1 Scope

This document specifies the basic requirements for pharmaceutical logistics services, as well as personnel and training, facilities and equipment, information systems, warehousing, transportation and distribution, Requirements for loading, unloading and handling, handover, value-added services, information management, risk management, complaint handling, service evaluation and improvement. This document applies to pharmaceutical logistics services and management activities. This document does not apply to in-hospital logistics services and management activities of pharmaceutical hospitals.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB 2894 Safety signs and guidelines for their use GB 13495.1 Fire safety signs Part 1.Signs GB/T 18354 Logistics terminology GB/T 28842 Pharmaceutical cold chain logistics operation specifications Pharmacopoeia of the People's Republic of China

3 Terms and definitions

The terms and definitions defined in GB/T 18354 and GB/T 28842 apply to this document.

4 basic requirements

4.1 A pharmaceutical logistics service management system should be formulated. 4.2 Operations such as drug warehousing, transportation and distribution, loading, unloading and handling, facilities and equipment, information systems, traceability, safety, emergency response, and internal audits should be formulated. process. 4.3 Emergency plans should be formulated for all aspects of drug storage, transportation and distribution, and emergency plan drills should be held regularly. 4.4 Organizational structure and position personnel suitable for pharmaceutical logistics services should be allocated. 4.5 There should be infrastructure, equipment tools and information systems suitable for pharmaceutical logistics services.

5 People and training

5.1 Pre-job and annual health examinations should be conducted for personnel who are directly exposed to drugs in pharmaceutical logistics services and management activities, and a health check-up system should be established. file. Those suffering from infectious diseases or other diseases that may contaminate medicines should not engage in work with direct contact with medicines. 5.2 An annual training plan should be formulated and training should be carried out as planned. Training content should include but not be limited to relevant laws and regulations, professional knowledge, positions Operating procedures, safety protection, emergency drills, etc. 5.3 Training records should be kept and training related situations should be evaluated. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 30335-2023_English be delivered?

Answer: Upon your order, we will start to translate GB/T 30335-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 2 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 30335-2023_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 30335-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 30335-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 30335-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.