医药行业标准T 0567.1-2005 医疗产品的无菌加工第1部分通用要求.pdfVIP

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医药行业标准T 0567.1-2005 医疗产品的无菌加工第1部分通用要求.pdf

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ICS 11.080 C 47 中华人民共和国医药行业标准 YY/T0567.1-2005/ISO 13408-1:1998 医疗产品的无菌加工第 1部分:通用要求 Asepticprocessingofhealthcareproducts- Part1:Generalrequirements (ISO 13408-1:1998,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/ISO 13408-1:1998 目次前言 ··················································································································…… 皿引言 ··················································································································…… N 1 范围 ··，············································································································…… 1 2 术语和定义 ································································································.·...…… 1 3 质量管理体系 ·····························································… … 4 4 人员 ···············································································································…… 5 5 设施设计 ·········································································································…… 6 6 无菌加工区(APA)·································································.···…… 6 7无菌加工区以外的辅助区 ····················································································……7 8 环境空气系统及其控制 ·······················································································……7 9 更衣 ·······················································，···················································…… 8 10 无菌加工区的清洁和消毒 ···················································································……8 n 设备、公用设施的鉴定和过程确认 ························

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医药行业标准T 0567.1-2005 医疗产品的无菌加工第1部分通用要求.pdfVIP