STP03-TY004-Ⅰ验证方案辽宁诺康生物制药有限责任公司设备工程部目录1目的··············································································32范围··············································································33职责··············································································34内容··············································································34.1概述············································································34.2验证小组成员及职责······························································34.3验证时间········································································44.4验证人员的培训··································································44.5文件检查········································································44.6性能确认········································································44.7空调系统的再验证周期···························································104.8漏项及偏差处理································································114.9验证最终结论··································································115附录············································································111目的核实针剂车间空气净化系统的设计、安装符合要求，资料和文件齐全。为证明空调净化系统能够保证车间各洁净区域所需技术参数达到GMP（98年版）关于洁净厂房的要求，满足产品生产工艺对环境洁净级别的要求，特制订本验证方案。2范围本方案适用于针剂车间空气净化系统性能确认的验证。3职责验证小组对本方案的实施负责。4内容4.1概述本次验证车间位于车间二楼，用于针剂生产车间，总面积1638m²，其中净化区面积905m²。由吉林医药设计院设计，沈阳天马医药工程安装有限公司施工。车间空气净化采用初、中、高效三级处理，洁净区内采用顶送侧下回，净化空调风量分别是14000m³/小时和15000m³/小时，万级净化空调风量27000m³/小时，送回风方式为顶送侧下回。在送风管道装有臭氧发生器用于系统消毒灭菌。本公司针剂车间空调系统于2007年6月份完成了安装确认、运行确认、性能确认等系统验证，已经证明该系统可以保证针剂车间内洁净区所需技术参数达到GMP（98年版）关于洁净厂房的要求，且满足生产工艺。本次针剂车间空调系统再验证针对其性能进行检测，因此只做性能确认。4.2验证小组成员及职责4.2.1验证小组成员小组职务姓名所在部门职务负责人郁野副总经理组长王弘设备工程部经理组员沈文彧质量管理部经理组员宋宇春生产技术部经理组员于彦空调岗位操作工44.2.2.1验证小组负责人：负责验证方案、验证报告的批准；负责从验证方案的起草、方案的实施以及验证报告完成全过程的组织工作。4.2.2.2组长部门：设备工程部：负责验证方案的起草；组织验证方案的实施；参加验证方案、验证报告的会签等。4.2.2.3组员部门：质量管理部：负责组织验证方案、验证报告的会审、会签，对验证方案实施的全过程监督。负责验证的协调工作，保证验证实施过程严格执行验证方案的规定。负责建立验证档案，归档验证资料；负责针剂车间空调净化系统验证实施过程中的监测、检测以及记录和报告工作