制药企业从事医疗器械生产需注意的几个问题  

Some Problems Involving in the Production of Medical Devices for Pharmaceutical Enterprises

作　　者：冯荣权 FENG Rong-quan(Zhejiang Kangde Pharmaceutical Group Co.,Ltd.,Zhejiang Quzhou 324000)

机构地区：[1]浙江康德药业集团股份有限公司,浙江衢州324000

出　　处：《中国医疗器械信息》2020年第15期27-28,58,共3页China Medical Device Information

摘　　要：药品和医疗器械的质量管理有许多相似之处,但也存有一些差异,制药企业从事医疗器械生产时需注意:①药品纯化水系统取样点一般包括二级反渗透出水口、纯化水贮罐、总送水口、总回水口,而医疗器械纯化水系统取样点一般包括总送水口、总回水口及管路最远端取样点;②药品洁净区检测指标包含照度,而医疗器械洁净区无照度要求;③药品质量管理体系包含生产全过程,而医疗器械质理管理系包含产品设计开发、生产和服务的所有过程,包含过程较为全面,有助于前后过程顺畅衔接。There are many similarities in the quality management of drugs and medical devices,however there are also some differences.When pharmaceutical enterprises engage in the production of medical devices,some problem must be paid attention to:①The sampling points of taking purified water system for drug generally include two stage reverse osmosis outlet,storage tank of purified water,main water supply outlet and main water return outlet,while the sampling points of purified water system for medical device generally include main water supply outlet,main water return outlet and sampling point at the farthest end of pipeline;②Illuminance is included in the detection index of drug clean area,however there is no illuminance requirement in medical device clean area;③Whole processes of production is included in the pharmaceutical quality management system,while quality management system for medical device includes all the processes of product designdevelopment,production and service,which isa more comprehensive and conducive process to the smooth connection between the front and back.

关 键 词：药品 医疗器械 生产质量管理 差别 

分 类 号：R197.39[医药卫生—卫生事业管理]