YYT0567.1-2005医疗产品的无菌加工第1部分通用要求.pdf

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1、ICS11.080C47中华人民共和国医药行业标准YY/T0567.1-2005/ISO13408-1:1998医疗产品的无菌加工第1部分:通用要求Asepticprocessingofhealthcareproducts-Part1:Generalrequirements(ISO13408-1:1998,IDT)2005-04-05发布2006-01-01实施国家食品药品监督管理局发布YY/T0567.1-2005/ISO13408-1:1998目次前言··································································

2、················································⋯⋯皿引言··················································································································⋯⋯N1范围··，············································································································⋯⋯12术语和定义···

3、····························································································....⋯⋯13质量管理体系····························································...............................·......⋯⋯44人员······················································································

4、·························⋯⋯55设施设计········································································································⋯⋯66无菌加工区(APA)··································································.·.........·.............⋯⋯67无菌加工区以外的辅助区·······································

5、·············································⋯⋯78环境空气系统及其控制·······················································································⋯⋯79更衣·······················································，···················································⋯⋯810无菌加工区的清洁和消毒·····················

6、······························································⋯⋯8n设备、公用设施的鉴定和过程确认·································································⋯⋯’·’“‘912传递至无菌区的材料和设备········································································⋯⋯‘·“二‘二913加工时间·········································

7、·················································..··········⋯⋯1014环境监视规程························································································........⋯⋯1015替戒线和措施线··········································