药品企业生产设备管理浅析

Analysis on The Management of Production Equipment of Pharmaceutical Enterprises

药品的生产主要通过设备实现,产品质量及生产规模都依赖于设备运行状态。为了尽可能降低药品在生产和加工过程中交叉污染的风险,持续稳定生产出质量稳定符合要求的药品,生产企业应当按照《药品生产质量管理规范》(药品GMP)的要求,对于生产过程中的设备进行系统化管理,以控制设备这一要素。虽然设备千差万别,不同工艺需要不同设备。但是对于设备的管理,企业可以通过文件和记录建立设备管理体系,按照设备的生命周期进行管理,使设备在整个生命周期内处于有效控制状态并持续保持。并且做到设备活动有文可依,有据可查。设备生命周期自采购计划、设备选型始,至安装、使用、维护保养、至报废终。药品GMP(2010)的第五章对于设备的设计、安装、维护维修、使用和清洁、校准等做出了详细的规定。将管理要求与设备全生命周期有机结合,将设备确认融入到设备全生命周期,同时,将风险评估和变更控制融入到设备的生命周期管理,这样能更好的符合药品GMP的要求。

the production of drugs is mainly realized by equipment.Product quality and production scale largely depend on the operating status of equipments.In order to minimize the risk of cross contamination in the production and processing of drugs and produce drugs with stable quality continuously and stably,the production enterprise shall carry out systematic management on the equipment in the production processs according to the requirements of GMP.Although different process needs different equipment,the enterprise can manage its production equipments according to the life cycle and establish equipment management system by documents and records.By these measures,the enterprise can keep the equipment under effective control throughout its life cycle and has documents to follow and evidence to check through equipment activities.The life cycle of the equipment starts from the purchase plan and equipment selection to the installation,use,maintenance and scrapping.Chapter 5 of GMP(2010)has made detailed regulations on the design,installation,maintenance,use,cleaning and calibration of equipment.The enterprise should integrate management requirements,equipment validation,risk assessment and change control into the whole life cycle of equipment to meet the requirements of GMP better,