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1、This module serves as a guide to the auditor in completing an audit of the process of receiving, storing, handling and testing Concentrate and Beverage Base. The auditor will determine whether or not the facility is complying with the specifications and requirements of The XXX Company by completing
2、this audit module.此模块为审核员完成对浓缩液和果汁主剂接收,储存,处理和测试过程进行审核提供指导. 审核员完成此模板可以确定该工厂是否符合XXX公司的规范和要求Plant工厂: Date日期: Auditor(s)审核员: 1) Questionnaire调查表:YesDivNoConcentrate / Beverage Base: 浓缩液/果汁主剂1Does the plant follow all requirements on the storage and handling conditions of Concentrates and Beverage Bases?
3、 工厂是否按照所有的浓缩液和果汁主剂的储存和处理条件的要求?2Does the plant store the Concentrate and Beverage Base in a dedicated, separate area with controlled access?工厂是否做到将浓缩液和果汁主剂标识清楚且单独存放在受控区域?3Are GMP issues covered for the storage of Concentrate & Bev. Base?GMP要求是否适用于浓缩液和果汁主剂的存储?4Are all Bulk Storage related issues cover
4、ed (if applicable)?大批量存储的相关要求有没有执行?2) Reference Standards List参考标准清单::Beverage Operations Manual饮料操作手册BO-RQ-020Concentrates & Bev. Bases Storage & Handling Requirem.浓缩液和果汁主剂储存和处理要求BO-RQ-200Good Manufacturing Practices Design Criteria良好操作习惯-设计标准BO-RQ-046Concentrates & Beverage Bases Bulk Tanker Requi
5、rements浓缩液和果汁主剂大批罐装要求BO-RQ-205Good Manufacturing Practices Bulk Storage Facilities良好操作习惯-大批罐装设备3) Specifications and Requirements Summary标准和要求概要:Specifications / Requirements标准/要求Concentrate / Beverage Base:浓缩液/果汁主剂1Does the plant follow all requirements on the storage and handling conditions of Con
6、centrates and Beverage Bases?工厂是否遵照所有的浓缩液和果汁主剂主要成分的储存和处理条件的要求做The requirement for Thermometers with alarms is in BO-RQ-200.对温度报警器的要求,见BO-RQ-200.In most cases, the Concentrate and Beverage Base package labels will contain storage conditions (temperature) and Use Before Dates. In these cases, this sup
7、ersedes the specific conditions listed below-right.大多数情况下,浓缩液和果汁主剂的包装标签包含储存条件(温度)和使用到期日期,在这些情况下,参考右边下面的详细的条件Concentrate and Beverage Base packages are to be sealed at all times. 任何时候浓缩液和饮料的包装都要密封BO-RQ-020 Documented procedure to be available on the storage and handling of Concentrate and Beverage Ba
8、se.在浓缩液和果汁主剂的贮存处理需要文件化,并具有可行性。 Continuous monitoring of storage temperature with alarms. 持续的温度报警监控系统 System allowing full traceability on the Concentrate / Bev. Base. 浓缩液和果汁主剂具有可追溯性 SOP in place to execute FEFO (First Expire First Out) SOP标准操作程序严格按照先到期先出原则执行 SOP in place to allow identification of s
9、torage time for each lot SOP应有每批(浓缩液和果汁主剂)贮存时间的记录 Maximum Storage Times and Temp. Conditions are followed:贮存时间及温度的最大极限,条件如下:- best before date and temp. conditions indicated on labels 最好在标签标明的贮存期限及温度条件下保存 If ambient storage temp exceeds 30C for 8 hours, transfer to cold storage (especially Concentra
10、te part 2)如果周围环境的温度超过30C,或时间超过8小时,及时转换或冷冻储藏(尤其对于第二成分) Bulk containers of Concentrate or Bev Base are not to be split大桶的(浓缩)饮料原料包装不允许有破口 Concentrate and Beverage Base not to be sent to other plants. 浓缩液和果汁主剂不允许送往其他加工厂Total Allowed Storage Times (from date of production); 总共允许的存储时间(从生产日开始计算)- Conc. pa
11、rt 1&2 / Diet Coke part 2: 4 10 C *12 months- 浓缩第一&第二成分/可乐第二成分: 4 10 C *12 个月 11 30 C 60 days 11 30 C 60 天- Diet Coke / TAB part 1: 11 30 C12 months- 可乐/TAB第1成分: 11 30 C12个 月- Beverage Base liquid parts: 4 10 C12 month- 饮料液体成分: 4 10 C12 个月 11 30 C *60 days 11 30 C 60 天- Beverage Base dry parts: 11 3
12、0 C12 months- 饮料干燥成分: 11 30 C12 个月- Past. juice cont. BB (liquid): 4 10 C *12 months- 果汁成份BB(液体) 4 10 C12 个月 11 30 C40 days 11 30 C40 天- Non-pasteurized juice containing BB (liquid) & un-preserved - 未经巴氏杀菌的果汁成分BB(液体)和未经防腐的浓缩果汁- fruit juice concentrate:-20 - -16 C12 months- 浓缩液: -20 - -16 C12 个月- Non
13、-pasteurized juice containing BB (liquid): 4 C 7 days- 未经巴氏杀菌的果汁成分BB(液体): 4 C 7 天 - Preserved fruit Juice concentrates: -18 -8C *12 months- 防腐的果汁浓缩液: -18 -8C *12 个月 4 10 C 40 days 4 10 C 40 天*: Written Division Approval is required. 区域认可的要求2Does the plant store the Concentrate and Beverage Base in a dedicated, separate area with