U-GMP.pptVIP

Inside the Storage Areas (4)在储藏区内 All workers have to be prepared for questions regarding the SOPs of the 所有的员工必须准备关于标准操作规程的问题 acceptance of material物料的接收 cleaning 清洁 exchange of status labels 状态标签的更换 and transfer of material 物料的传递 * Inside the Storage Areas (5)在储藏区域内 They will ask for the exact procedure how incoming raw material is treated, and they want to see the SOP. A clear division between released (green), quarantined (yellow) and rejected (red) products is required. “Reds” have to be in a locked room or in a locked cage. 他们会要求准确的程序，原辅料进来后的预处理，他们希望看到SOP文件。要求严格的区分放行（绿色），待验（黄色）和不合格（红色）的产品。“红色”的产品必须要锁在房间里或铁丝网笼里。 * Inside the Laboratory (1) 在化验室内(1) The auditors will have a quick look at every piece of equipment. A quick check of log books of selected items is usual. Calibration records and validation records are required (if they are stored some where else, they will be checked later). Validation of the HPLC injection volume might be a question. 审查员将简短的查看设备的每个部件。通常还要选出一些项目对工作记录台帐进行一个简短的检查。还需要检查校准报告和验证报告（如果报告被放在其他什么地方，检查员会晚些检查）。HPLC的注射量的验证可能会成为一个问题。 * Inside the Laboratory (2) 在化验室内(2) Storage room for reagents has to be completely renovated. Holes in wall covered with cement, white paint on the wall, new shelves, all reagents need label and all reagents have to be cleaned. When reagents are stored in boxes, the boxes have to be labeled. Organise a system and may be store cards. 试剂储存室必须完全更新。墙上的洞要用水泥封好，粉刷墙面，新货架，所有试剂要贴标签以及清洁。如果试剂存放在盒子里，盒子必须贴标签。做好储存货位卡。 * Inside the Laboratory (3)在化验室内 (3) They also expect that the validations of the equipment has been done with the APIs and the excipients which are used for the European products. They will ask for the validation of all used APIs with HPLC, IR and/or GC. 检察官要看到检测设备以相关产品所做的验证。他们将要求看到所有用HPLC, IR 或 GC检测的相关API的验证 * Inside the Laboratory (4)在化验室内 (4) All workers have to be prepared for questions regarding the SOPs of the 所有的员工必须准备关于标准操作规程的问题 acceptance of ma