欧盟GMP和卫生消毒研讨会课件.pdf

EU-GMP regulations on Hygiene and Disinfection 欧盟GMP卫生和消毒相关条例 Dr. Christian Wippo International Business Development Life Sciences Foodtec European GMP EU-GMP Guidelines on Hygiene 欧盟GMP卫生和消毒相关条例 Key Guidelines Regulations 主要法规规范 Other important regulations 其他重要的法规、规范 EU GMP Guidelines 1 Pharmaceutical Quality System ISO Standards ISO标准 药品质量体系 European Norm (EN) 欧盟标准 2 Personnel 人员 3 Premises and Equipment 房屋和设备 European Pharmacopoeia 欧洲药典 4 Documentation 文件 5 Production 生产 Pharmaceutical Inspection Convention 6 Quality Control 质控 Scheme PIC/S 药品检查合作组织 7 Outsourced activities 外包 8 Complaints and Product Recall 投诉和召回 International Conference on Harmonisation 4 Self Inspection 自查 […] ICH Guidelines Annex 1 – 19 附录 国际（药品注册）协调会议 Key points on Hygiene Disinfection 与卫生消毒相关的关键点 Key Areas for GMP Hygiene GMP卫生关键 Raw Materials原材料 Air Water 空气水 Personnel人员 Entry of contaminants 污染源 Facility设施 Machinery机器 Equipment设备 Spreading of contaminants 扩大污染 Disinfection消毒 Removal of contaminants 去除污染 Sampling采样 Monitoring监测