无菌制剂的GMP认证.pptxVIP

ISPE-CCPIE CHINA CONFERENCE 2012 GMP Certification of Aseptic Facility - in relation to Annex 1 Requirements 无菌工厂的GMP认证 -中国新版无菌附录1 September 24-25 2012 Beijing 1 Content 内容 • • • • • • • • • • • • New regulation Annex 1 – key changes Current facility Gap analysis and Risk Assessment Engineering Qualification/Validation work Documentation to SFDA GMP新版附录1-主要变化 现有厂房 差异分析和风险评估 工程改造 验证工作 申报文件准备 ISPE-CCPIE CHINA CONFERENCE 2012 2 New Annex 1 – key changes 新版附录1 1-主要变化 • Article 13 – NOTE 1: • ‘Container closure system … is not fully integral until the aluminium cap has be