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1、本模块作为审核指南，完成模块中内容的考核以确定被审公司是否符合可乐要求1) Questionnaire:YesDivNo1. Does the warehousing area meet the specified GMP design criteria?2仓库符合特定的GMP要求吗2. Does the plant comply with the Storage and Handling Requirements for Finished Products?2成品的贮存与处理符合要求吗3. Does the plant follow the specific warehousing requ
2、irements for REFPET, Refillable Glass, Cans?2仓库对回收PET、回收玻璃瓶和罐要求符合吗4. Has the plant a Warehouse Management system in place?2有仓库管理系统吗5. Does the plant use the correct primary age specifications?2工厂用的是最新标准吗6. Does the plant handle over-aged and non-conforming products according to the Company requireme
3、nts?3是按公司要求处理过期产品和不合格品的吗7. Does the plant comply with the Shipping Requirements?3工厂符合运输要求吗8. Is traceability maintained throughout the supply chain?3整个供应链具备可追溯性吗9. Are responsibilities clearly defined for external warehouses used by the plant?错误！未定义书签。对外部仓库的职责工厂已明确界定了吗2) Reference Standards List:Bev
4、erage Quality Manual BO-RQ-925Material and Product Identification StatusBO-RQ-801ShippingBO-RQ-200Good Manufacturing PracticesBO-RQ-195Finished Product Storage and HandlingBO-RQ-800Product RotationBO-SP-167Primary Age SpecificationsBO-RQ-905Control and Distr. of Non-Confirming Trademarked Materials
5、& ProductsBO-RQ-930TraceabilityBO-RQ-014Package Materials RequirementsDivision Operations Manual DO-RQ-115Packaging Requirements (Policy)Fountain Quality Manual FV-SP-225Postmix Beverage specificationsTCCQS updates are captured till December 15, 20053) Specifications and Requirements Summary:Specifi
6、cations / Requirements1Does the warehousing area meet the specified GMP design criteria?仓库设计是按GMP要求设计的吗The items listed here are “approved conditions” to the requirement: “Prevent contamination or degradation of Finished Products”.The pallet repair area and the finished goods destruction (plant wast
7、e) area are typical examples of potential contamination areas. They must not be located in the warehouse. Precautions must be taken to avoid cross-contamination.托板修理和成品报废区是典型的潜在区，所以不能设在仓库内，须采取措施防止交叉污染BO-RQ-200 Warehouse entrances to be equiped with air curtains or quick opening doors (no unprotected
8、 open gates) 仓库入口需安装门帘或自动门（不允许存在无防护的门） Insect killers and pest control at entrances 杀虫器与虫鼠控制装置应装在入口处 Warehouse area located in coolest area of the plant 仓库区应位于工厂阴凉的位置 Avoid direct sunlight and freeze 避免直接日照和冷冻 Area has ventilation system if it is enclosed, usually 2-4 changes / hour 若库区为封闭的，应有通风装置；通
9、常换气2-4次/小时. Adequate lighting with protective shields; no use of mercury vapor bulbs 照明充足，灯有灯罩；不能用含汞的照明灯 Floors from a smooth, easily cleanable material, non-toxic 地板光滑易清洗，为无毒材料 Seal all joints between walls and roof Pallet rows and racking starts away from the walls (typically meter to allow person
10、nel for cleaning) 栈板离墙墙壁（通常是半米以便工作人员清洗） Paint a strip m wide next to the walls, using high gloss epoxy paint. 靠墙画一条半米宽的区域；用高光环氧漆 Slope all wall ledges to keep dust and trash from building up and make cleaning easier. 所有壁架应做成倾斜的，以利于清扫，防止灰尘及废弃物的堆积2Does the plant comply with the Storage and Handling Re
11、quirements for Finished Products?工厂就成品的贮存和处理符合公司要求吗The recommended storage temperature is 10 to 20 C.Exposure to high temperature must be avoided.推荐贮存温度在10 至 20 C，不能曝于高温中Diesel forklifts usually generate diesel dust on the pallets in the warehouse. Diesel dust on the pallets is considered as contami
12、nation.柴油叉车产生柴油灰尘于托板上，这可被认为一种污染The presence of animals (any kind) in the warehouse is a clear sign of potential contamination.仓库区有动物可是一个潜在的污染Pallets in the warehouses to be clean and not covered with dust.仓库中的托板要清洁并无尘BO-RQ-195 Develop and implement a product storage and handling procedure that inclu
13、des: 制定并执行产品储存和处理程序包括- Inventory rotation using FEFO- 保证先到期先出库- Protection from damage, deterioration, contamination- 保护产品不受损，不变质，不受污染- Wooden pallets treated with chemicals that may leave - 用化学处理过的木板- residues that can permeate packages and cause off-odors or off-tastes to product are not in use.-
14、Security of the storage areas,- 储存区的安全- Record keeping- 保存记录- Operate with compliance with GMP requirements- 按照GMP要求操作- Store product in a clean, ventilated, rodent and vermin-free warehouse- 把产品放在干净、通风没有老鼠和害虫的仓库- Stock area is convenient to conduct a survey- 储存区方便查核- Segregate full goods, according
15、 to product, package and filling date to facilitate FEFO.- 按照产品、包装和灌装日期把货物隔离以利于FEFO的操作- Store at a cool temperature- 低温保存- Frost protection to be installed (if needed)- 安装防冻设施（如有必要）- If products are not intended to be frozen, become frozen while in storage, must be withheld from shipment until all quality parameters are confirmed. Otherwise they must be destroyed.- 如果产品在贮存时意外被冷冻了，则必须停止发货，以
