EU GMP 附录1：无菌药品（2020年02月20日修订草案）【中英文对照版】.docxVIP

PAGE 7 Annex 1 : Manufacture of Sterile Products 无菌药品的生产 Document map 目录 TOC \o 1-3 \h \z \u 8 Production and Specific Technologies生产与具体技术 2 Terminally sterilized products 最终灭菌产品 2 Aseptic preparation and processing 无菌准备和处理 2 Finishing of sterile products无菌产品的最终处理 6 Sterilization 灭菌 8 Sterilization by heat 热力灭菌 10 Moist heat sterilization 湿热灭菌 11 Dry heat sterilization 干热灭菌 13 Sterilization by radiation 辐射灭菌 15 Sterilization with ethylene oxide环氧乙烷灭菌 15 Filter sterilization of products which cannot be sterilized in their final container非最终灭菌药品的无菌过滤 16 Form-Fill-Seal 成型-灌-封 20 Blow-Fill-Seal 吹-灌-封 20 Lyophilization 冻干 22 Closed systems 密封系统 23 Single use systems (SUS) 一次性使用系统 24 9 Viable and non-viable environmental process monitoring 活性和非活性环境和工艺监测 26 General 综述 26 Environmental monitoring 环境检测 26 Environmental monitoring- non-viable particles 非活性粒子的环境检测 27 Environmental and personnel monitoring-viable particles 环境和人员的监测—活粒子 29 Aseptic process simulation (APS) (also known as media fill) 无菌模拟灌装 31 10 Quality Control (QC) 质量控制 38 Glossary 术语 40 8 Production and Specific Technologies生产与具体技术 Terminally sterilized products 最终灭菌产品 8.1 Preparation of components and materials should be performed in at least a Grade D cleanroom in order to limit the risk of microbial, pyrogen and particulate contamination, so that the product is suitable for sterilization. Where the product is at a high or unusual risk of microbial contamination (e.g. the product actively supports microbial growth, the product must be held for long periods before filling or the product is not processed mostly in closed vessels), then preparation should be carried out in a Grade C environment. Preparation of ointments, creams, suspensions and emulsions should be carried out in a Grade C environment before terminal sterilization. 部件和物料的准备工作至少应在D级洁净室中进行，以限制微生物、热原和微粒污染的风险，以便使产品适合灭菌。如果产品存在微生物污染的高风险或异常风险（例如产品适宜微生物的生长，必须在灌装之前将产品放置很长时间