XXXXX 文件名称File Name 纯化水系统用户需求说明User Requirement Specification for Purified Water System 设备 Equipment 纯化水系统 Purified Water System 设备编号 Equipment Tag XXXXX 日期Date XXXXX 文件编号 URS Code XXXXX康养基地管理实务 收集了康养基地相关制度、标准、项目以及相关资料等,供参考 专栏 相关精品...
Qualification Performance Qualification Computerized System Validation Purified water Water for injection Pure steam Total organic carbon Good Manufacturing Practices International Standards Organization Quality Assurance Standard Operating Procedures European Union –current Good Manufactu学ri习n指g 导P参ra考c资ti...
Purified Water./纯化水 WFI Water For Injeciton./注射用水 MWS Multiple Effect Water Still./多效蒸馏水机 HMI Human Machine Interface/人机界面 HDS Hardware Design Specifcation./硬件设计标准 SDS Software Design Specification./软件设计标准 SCADA System control &Data Acquisition System./数据采集与控制系统...
逐条点评:某药企提供的中药提取罐URS(一) 前几天,在蒲公英论坛写了一个文章“中药提取罐应该这样做FAT”文章在微信转载后,收到一些反馈和留言。 因为在上一篇提到,我说提取罐加工制作技术含量不高,有的厂家不同意,说他们的有技术含量,焊接啊、抛光啊。。解释...
4、 Testi ng现场验收测试IQInstallation Qualification安装确认OQOperational Qualification运行确认PQPerforma nee Qualificatio n性能确认CSVComputerized System Validati on计算机化系统验证PWPurified water纯化水WFIWater for injectio n注射用水PSPure steam纯蒸汽TOCTotal orga nic carb on总有机碳GMPGood Manu facturi...
(User Requirement Specification,URS)标标 题题洁净压缩空气分配系统编编 码码 文件编号/版本:WT-SOR-05-001/00 版 文件编号/版本:WT-SOR-05-001/00 7、 版 生效日期:2013.04.XX缩写缩写英文全称英文全称中文定义中文定义PWPurified water 纯化水WFIWater for injection注射用水PSPure steam 纯蒸汽TOCTotal ...
词汇gmppwwfipscipsipiqoqpqfatsatgoodmanufacturingpractices药品生产质量管理规范purifiedwater纯化水waterforinjection注射用水puresteam纯蒸汽cleaninplace在位清洗sterilizationinplace在位灭菌installationqualification安装确认operationalqualification运行确认performancequalification性能确认factoryacceptancetest出厂验收测试siteacceptancetest...
ØThe equipment is mainly used for the preparation of the solution of the wet granulator, fluidized bed and high-efficiency coating machine in the oral solid dosage workshop (line 1). The solution preparation vessel adopts the vertical jacketed tank, which can realize the heating of water bat...
AISIAmerican Iron and Steel Institute美国钢铁学会BIBiological Indicator 生物指示剂CIPClea n In Place在线清洗DQDesign Qualification 设计确认FSFunction Specification 功能标准FATFactory Accepta nee Testi ngX厂验收测试HMIHuma n -Mach ine In terface 人-机界面PWPurified Water 纯化水7.0 文件变更控制 Version...
Purified Water 5bar 5巴的净化水 Industrial Steam 6.5bar 6.5巴的工业蒸汽 Compressed Air 6 bar 6巴的压缩空气 The supplier shall provide the consumption details of each utility including minimum, average and peak flows. 供应商应当提供每种公用设施的从最小到中间到峰值的消耗量。 4.1.2 Materials 材质...