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Refrigerated truck information

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GSP related vaccine vaccine refrigerated truck
Release time: 2017-03-19 16:01:55 Source: itforthai.comViews :

输运疫苗必须符合要求,需要通过 GSP 认证。 Vaccine Refrigerated trucks must meet the requirements for vaccine delivery and must pass GSP certification.   认证? GSP certification? 是《药品经营质量管理规范》的英文缩写,是药品经营企业统一的质量管理准则。 GSP is the English abbreviation of "Goods Management Quality Management Standards" and is a uniform quality management standard for pharmaceutical business enterprises. GSP 要求,并通过认证取得认证证书。 The drug trading enterprise shall meet the GSP requirements within the time specified by the drug supervision and administration department , and obtain the certification through certification.

      GSP Pharmaceutical company GSP   4601 条和 4701 条对药品运输有明文要求:对有温度要求的药品的运输,应根据季节温度变化和运程采取必要的保温或冷藏措施。 In the certification requirements, Articles 4601 and 4701 have explicit requirements for the transportation of drugs: For the transportation of drugs with temperature requirements, necessary insulation or refrigeration measures should be taken according to seasonal temperature changes and transportation processes. The transportation of drugs and dangerous goods under special management shall be handled in accordance with relevant regulations.

      GSP 认证,中涉及到对冷藏药品储存和运输的范围和内容,包括对冷库、 冷藏车 、冷藏箱、保温箱以及温湿度自动监测系统(以下简称监测系统)等进行验证,确认相关设施、设备及监测系统能够符合规定的设计标准和要求,并能安全、有效地正常运行和使用,确保冷藏、冷冻药品在储存、运输过程中的质量安全。 The GSP certification of the “Good Manufacturing Practice” issued by the State Food and Drug Administration refers to the scope and content of refrigerated medicine storage and transportation, including automatic monitoring of cold storage, refrigerated trucks , refrigerated boxes, heat preservation boxes, and temperature and humidity. System (hereinafter referred to as the monitoring system) to verify that relevant facilities, equipment and monitoring systems can meet the specified design standards and requirements, and can operate and use normally and safely, and ensure that refrigerated and frozen medicines are stored and transported Quality safety.

      GSP 认证到底有哪几项呢? What kinds of GSP certifications does the CFDA have for drug refrigerated trucks ?

疫苗冷藏车车厢内温度分布特性的测试与分析,确定适宜药品存放的安全位置及区域; 1. Test and analysis of the temperature distribution characteristics in the compartment of the vaccine refrigerated truck to determine the safe location and area suitable for drug storage;

、温控设施运行参数及使用状况测试; 2. Test of operating parameters and operating conditions of temperature control facilities;

监测系统配置的测点终端参数及安装位置确认; 3. Confirm the terminal parameters and installation position of the monitoring system configuration;

、开门作业对车厢温度分布及变化的影响; 4. The influence of door opening operation on the temperature distribution and change of the carriage;

、确定设备故障或外部供电中断的状况下,车厢保温性能及变化趋势分析; 5. Determine the thermal insulation performance and change trend of the car under the condition of equipment failure or external power supply interruption;

、对本地区高温或低温等极端外部环境条件,分别进行保温效果评估; 6. To evaluate the effects of thermal insulation on extreme external environmental conditions such as high or low temperatures in the area;

、在冷藏车初次使用前或改造后重新使用前,进行空载及满载验证; 7. Perform no-load and full-load verification before the first use of the refrigerated truck or before re-use after the transformation;

、年度定期验证时,进行满载验证。 8. During annual regular verification, full load verification is performed.  

  The State Food and Drug Administration's regulations for the transportation of drugs and vaccines by pharmaceutical companies and epidemic prevention departments must meet the following conditions:

、运输药品及疫苗的冷藏车必须是双温控,也就是说制冷制热的功率与箱体相匹配,能够确保在 15-20 分钟内达到 2 8 度。 1. The refrigerated truck that transports medicines and vaccines must be dual temperature controlled, that is, the power of cooling and heating is matched with the box, which can ensure that it can reach 2 to 8 degrees in 15-20 minutes .

、疫苗冷藏车的保温性能要好,以避免制冷机组连续工作,要求车辆经济实用。 2. The thermal insulation performance of vaccine refrigerated trucks should be good to avoid the continuous operation of the refrigeration unit, which requires the vehicles to be economical and practical.

、符合药监局认可的 GSP 认证要求。 3. Meet the GSP certification requirements recognized by the FDA .

、在极端温度下必须符合需方温度要求。 4. Must meet the demand-side temperature requirements under extreme temperature.

、疫苗冷藏车的防盗门必须结实符合防盗要求。 5. The anti-theft door of vaccine refrigerated truck must be strong and meet the requirements of anti-theft.


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