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1、本模块作为审核指南，完成模块中内审的考核以确定被审公司是否符合要求1) Questionnaire:YesDivNo1. Does the plant follow all requirements on the storage and handling贮存和处理符合要求吗22. Does the plant store the Concentrate and Beverage Base in a dedicated, separate area with controlled access?2贮存区是个专区吗，出入受控吗3. Are GMP issues covered for the st
2、orage of Concentrate & Bev. Base?2GMP范围涵盖了这一块吗4. Are all Bulk Storage related issues covered (if applicable)?大宗贮存问题考虑到了吗25. Does the plant follow all the requirements on powder dry mix manufacturing?工厂粉剂生产符合求吗32) Reference Standards List:Beverage Operations ManualBO-RQ-020Concentrates & Bev. Bases S
3、torage & Handling Requirem.BO-RQ-200Good Manufacturing Practices Design CriteriaBO-RQ-046Concentrates & Beverage Bases Bulk Tanker RequirementsBO-RQ-205Good Manufacturing Practices Bulk Storage FacilitiesBO-RQ-910PurchasingBO-RQ-570Powder Dry Mix ManufacturingTCCQS updates are captured till December
4、 15, 20053) Specifications and Requirements Summary:Specifications / RequirementsConcentrate / Beverage Base:1Does the plant follow all requirements on the storage and handling conditions of Concentrates and Beverage Bases?贮存和处理符合要求吗Alarm is highly recommended高度推荐警设备In most cases, the Concentrate an
5、d Beverage Base package labels will contain storage conditions (temperature) and Use Before Dates. In these cases, this supersedes the specific conditions listed below-right.大多数情况下，浓缩液主剂标签内容有贮存条件，使用日期，在这种情况下：要求特殊的贮存条件列于右下角Concentrate and Beverage Base packages are to be sealed at all times.浓缩液和主剂一直是
6、密封的 BO-RQ-020 Documented procedure to be available on the storage and handling of Concentrate and Beverage Base. 要有主剂贮存与处理的的文件 Continuous monitoring of storage temperature with recording devices or alarms. 对贮存区要连续温度监控，并要有记录或是报警 Tracking system implemented to record lot numbers of all incoming materi
7、als as they are received 按追溯要求，当接受来料时要记录下批号 SOP in place to execute FEFO (First Expire First Out) 有SOP规定执行FEFO Storage conditions indicated on the container or printed on the label are followed. If not indicated, Company Division technical is contacted for guidance and corrective action. 贮存条件显示于容器上或
8、是打印在随行的标签上，如没有，则公司技术部与之联系采取纠正措施。o Non-refrigerated (ambient): 11C to 30C (must not exceed 30C)o 室温：11C to 30C，不能超过30Co Non-refrigerated (cool): 11C to 20Co 清凉1C to 20Co Refrigerated (cold): 4C to 10Co 冷4C to 10Co Chilled: 0C to 4Co 冻：0C to 4Co Deep-frozen: -20C to -16C; target is -18Co 深冻 -20C to -1
9、6C Concentrate or Beverage bases beyond the expiration date or Best before date printed on the container are not used. If not indicated, Company Division technical is contacted for guidance and corrective action. 主剂、浓缩液、和有效期或最佳使用期等内容和贮存条件显示于容器上或是打印在随行的标签上，如没有，则公司技术部与之联系采取纠正措施。 Refrigerated and froze
10、n Beverage bases that are stored at ambient are stored in such conditions for a maximum of 2 days before use 在冻库中了取出主剂至室温区最长不超过2天 Bulk containers of Concentrate or Bev Base are not to be split 大容器的浓缩液和主剂不能拆分 Concentrate and Beverage Base not to be sent to other plants unless Division approved.没有公司的许
11、可，浓缩液不能运于其余公司2Does the plant store the Concentrate and Beverage Base in a dedicated, separate area with controlled access?贮存区是个专区吗，出入受控吗BO-RQ-020 / BO-RQ-200 Stored in a dedicated area with access restricted to authorized personnel only. 贮存于专区，仅由专人进出。 Separately from other non-food materials.与非食品类分开
12、 3Are GMP issues covered for the storage of Concentrate & Bev. Base?GMP范围涵盖了这一块吗One must be able to walk and clean between pallets and walls. BO-RQ-200 No possibilities for contamination or deterioration of quality 没有被污染或变质的可能 Easy cleanable floors / clean area / adequate lighting. 地板易清洁/清洁区/充足灯光 Al
13、l pallet rows and pallet racking away from the walls 所有的托板排列不能靠墙4Are all Bulk Storage related issues covered (if applicable)?大宗贮存问题考虑到了吗BO-RQ-046 Visual inspection of receiving load 接受装运的目检 Record shipping temperature 运输的记录 Agitate the bulk tanker load to homogeneity before unloading 在卸料前的搅拌均匀 Agita
14、tion time is 1 hour 搅拌时间1个小时 Visual inspection of storage tank for cleanliness / good condition 目检贮存缸的卫生 Remnants (left overs) to be stored in clean containers (sealed) and to be added to next batch 残留贮于另一清洁容器内（密封）加入下一批。 Maintain traceability of remnants use 保持残留使用的可追朔性 Empty bulk tankers to be visu
15、ally inspected, cleaned & sanitized, closed & sealed 空罐须目检，清洁、消毒、关闭和密封 Record system to guarantee traceability of Bulk Concentrate and Beverage Base deliveries. 记录要能保证大桶浓缩液和主剂运输的可追朔性BO-RQ-205 At least 2 storage tanks available for each Concentrate or Beverage Base part received in bulk 每次浓缩液和主剂接收时要保证有2个可用的贮缸 Load cells with accuracy of 0.1% 装载单位精度为 0.1% Agitators with automatic timers 搅拌器有自动记时器 All tanks
