欧盟药品GD及药品冷链技术全.pptVIP

Type of instrumentation (accuracy of +/-0.5?C) 仪器类型(准确度+/-0.5?C) Use of product temperature monitoring 用于产品温度监测 Alarm System 报警系统 Effects of Normal Operation 正常运行的效果 Out of Hours Response 对非正常运行的响应 Tested 进行测试 Fridge/Freezer Temperature Monitoring 冷藏/冷冻温度的监测 Annually 每年校准 Against a certified, traceable reference standard 用经过鉴定的，具有可追踪的参照标准进行校准（对照） Records of calibration should be maintained 应保存校准记录 Calibration 校准 Procedure for temperature recording should be documented 应有书面的温度记录的规程 Format of the records 记录有规定的格式 Review 有人审核 Independent review by the person responsible for the storage area 储存区责任人进行独立审核 Procedure for notification of excursions outside of specified limits 有温度偏离规定限度的通报程序 Investigation of excursions, consideration of the impact on product, and implementation of corrective actions 调查温度偏离，考虑其对产品的影响，实行纠偏措施 Temperature Recording 温度记录 Considerations in Selecting a Transportation System 选择一个运输系统应考虑的问题： Nature Size of the load 所装载的性质与大小 Temperature control requirements of the load 装载对温度的控制要求 Method of transportation 运输方法 Duration of transportation 运输时间 Local seasonal temperatures 地区不同季节的温度 情况 Cold Storage Transportation Systems冷藏运输系统 Small Volume Systems 小容量系统 Chill packs may also be incorporated 可考虑采用冷却袋 May be of different sizes to incorporate smaller, medium, and larger volumes with the relevant capacity range 可能需根据能力来考虑大、中、小规格的不同组合 Typically suitable for smaller volume loads where the transit times are of limited duration e.g. deliveries from a wholesaler to a pharmacy 通常适用于小量药品的运输，如从一个批发仓库发往药房的短距、短时运输 Small Volume Transportation Systems小量运输系统 Qualification 确认 The system should be qualified to demonstrate its ability to maintain the required product temperature storage conditions 系统应经过确认，证实其保持产品储存温度的能力 Qualification should take into account 确认应当考虑以下因素： Maximum transit times 最长运输时间 Minimum and maximum packaging capaci