GB/T 28842-2021 PDF English
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GB/T 28842: Historical versions
| Standard ID | USD | BUY PDF | Delivery | Standard Title (Description) | Status |
| GB/T 28842-2021 | 170 | Add to Cart | Auto, 9 seconds. | Operation specifications for medicinal product cold chain logistics | Valid |
| GB/T 28842-2012 | 399 | Add to Cart | 3 days | Operation specification for drug cold chain logistics | Obsolete |
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GB/T 28842-2021: Operation specifications for medicinal product cold chain logistics
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT28842-2021GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 03.220.01 CCS A 87 Replacing GB/T 28842-2012 Operation Specifications for Medicinal Product Cold Chain Logistics Issued on: NOVEMBER 26, 2021 Implemented on: JUNE 1, 2022 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3 1 Scope... 6 2 Normative References... 6 3 Terms and Definitions... 6 4 General Requirements... 7 5 Personnel and Training... 7 6 Facilities, Equipment, and Verification Management... 7 7 Temperature Monitoring and Control... 8 8 Logistics Operations... 8 9 Emergency Management... 11 10 Internal Audit and Improvement... 11 Bibliography... 12 Operation Specifications for Medicinal Product Cold Chain Logistics1 Scope
This Document specifies the general requirements; personnel and training; facilities, equipment and verification management; temperature monitoring and control; logistics operations; emergency management; internal audit and improvement; and the like requirements for the medicinal product cold chain logistics. This Document applies to medicinal product cold chain logistics services and management.2 Normative References
The provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document. GB/T 34399 Temperature control facilities of pharmaceutical products cold chain logistics - Specification for performance qualification WB/T 1097 General specification for cold-chain insulated container of drug WB/T 1104 Road transport - Requirements of refrigerated vehicle functions for pharmaceutical products3 Terms and Definitions
For the purposes of this Document, the following terms and definitions apply. 3.1 Medicinal product cold chain logistics The logistics process that uses specialized facilities and equipment to ensure that the temperature of the medicine is always controlled within the specified range from production to use, in accordance with the temperature control requirements indicated in the approved registration certificate, instructions, and labels.4 General Requirements
4.1 Appropriate management and operational personnel shall be available, and personnel shall receive appropriate training. 4.2 Appropriate temperature control facilities and equipment shall be available, and these facilities and equipment shall be validated. 4.3 A temperature monitoring system shall be available to monitor and record the temperature throughout the entire logistics operation process; and the temperature data shall be traceable. 4.4 A quality management system document for medicinal product cold chain logistics shall be established, and operations shall meet the requirements of Clause 8. 4.5 An emergency management system shall be established and implemented. 4.6 An internal audit system shall be established, and corresponding improvement measures shall be developed based on the conclusions. 4.7 All original records and vouchers in the medicinal product cold chain logistics operation process shall be kept for at least 5 years. Paper records shall be clearly visible and prevented from fading; and electronic data and records shall be backed up off-site.5 Personnel and Training
5.1 A quality management department shall be established and staffed with dedicated quality management personnel. 5.2 Pre-employment and annual health checks shall be conducted for personnel who directly handle medicinal products; and health records shall be established. 5.3 An annual training plan shall be developed, training shall be conducted according to the plan, training records shall be kept, and training shall be evaluated. 5.4 Training content shall include, but is not limited to, relevant laws and regulations, professional knowledge, job operation procedures, safety protection, and emergency drills, and cold chain logistics personnel can only be employed after passing an assessment.6 Facilities, Equipment, and Verification Management
6.1 Cold storage warehouse, refrigerated trucks, refrigerated boxes, insulated boxes, or other dedicated temperature control facilities and equipment appropriate to the types of medicinal products and the scale of business operations shall be available. 6.2 The performance verification of temperature control facilities and equipment shall meet the requirements of GB/T 34399 and be used within the scope supported by verification results. 6.3 Cold storage warehouse shall be equipped with power failure alarms, standby generator sets, or dual-circuit power supplies. Standby generator sets shall be inspected and maintained regularly, and start-up and operation tests shall be conducted at least once a month, with records kept. 6.4 Refrigerated trucks shall comply with the provisions and requirements of WB/T 1104. 6.5 Insulated boxes shall comply with the provisions and requirements of WB/T 1097. 6.6 Extreme temperature environmental condition verification shall be conducted on different models of in-use refrigerated trucks, refrigerated boxes, and insulated boxes within the annual cycle. While ensuring consistency, the verification of in-use refrigerated trucks, refrigerated boxes, and insulated boxes of the same model and batch can be reasonably optimized according to the actual situation of the enterprise. 6.7 Verification control documents shall be established, including but not limited to verification plans, verification schemes, verification reports, change control, deviation handling, etc. Verification control documents shall be kept as required. 6.8 When the temperature exceeds the warning temperature during logistics operations, the automatic temperature monitoring system shall issue an alarm in real time.7 Temperature Monitoring and Control
7.1 When temperature deviations occur in cold chain logistics operations, the enterprise's quality management department shall be notified; and deviation handling shall be carried out in accordance with the requirements of the quality management system documents. 7.2 Temperature shall be monitored in real time. Temperature monitoring data shall be readable and archived. It shall be backed up off-site daily. The backup data storage location shall be secure.8 Logistics Operations
8.1 Receiving and Acceptance 8.1.1 The temperature of the receiving area shall conform to the temperature range indicated on the medicine's instructions and label. Cold chain receiving operations shall be completed within the receiving area or a buffer zone that, after assessment, shall not adversely affect the quality of the medicines. 8.1.2 During the transfer of medicines from refrigerated trucks to cold storage warehouse, protective and heat-insulating measures shall be taken based on verification results, and the medicines shall not be directly exposed to ambient temperature conditions. 8.1.3 Upon receipt, both the consignor and consignee shall simultaneously check the temperature displayed on the transportation facilities and equipment, as well as the ambient temperature. Special attention shall be paid to checking, recording, signing and confirming the temperature data1), transportation time, and the like quality situations; and shall be handled according to the following requirements. a) If the information2) is complete and meets the cold chain transportation temperature requirements, the consignee may accept the goods; b) For medicines with incomplete information but meeting the cold chain transportation temperature requirements, the consignee may temporarily store the medicines in an environment that meets the instructions for use until the information turns complete, at which point the receiving procedures shall be went through. c) Medicines whose temperature does not meet the requirements shall be isolated and stored in an environment that meets the instructions for use. The enterprise's quality management department shall be notified for handling, and the medicine manufacturer shall be contacted immediately. An assessment shall be conducted based on the opinions of all parties to determine whether to accept or reject the goods. d) Medicines for which temperature records of the transportation process cannot be provided shall be rejected. 8.1.4 During acceptance, the transportation method, temperature records during transportation, transit time, and arrival temperature, and the like quality situations shall be rechecked and reverified again. Acceptance shall be completed within the storage temperature environment specified in the medicine's instructions for use. 8.1.5 For medicines returned after sale, the temperature control documentation provided by the returning party and relevant temperature control data during the sales period shall be checked simultaneously. The operation shall be completed based on the assessment opinions of the enterprise's quality management department. 8.2 Storage and maintenance 8.2.1 A maintenance work plan shall be developed, key maintenance varieties shall be identified, and maintenance records shall be established. 1) Temperature data is divided into pre-receipt and post-receipt data. Pre-receipt temperature data is based on the temperature data from the accompanying thermometer or the vehicle's temperature display; post-receipt temperature data is based on the real-time monitoring data from the receiving warehouse. 2) The information includes, but is not limited to. accompanying documents (tickets), temperature records during transportation, etc. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
