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 been crimped into place on the stoppered vial’ 只有完成压盖操作才能视为是完整的密封体系 • Article 13 – NOTE 2: • • • Uncapped fully stoppered vials 未压盖的已全压塞的西林瓶 Protected by Grade A air supply – up to point of capping 在压盖前的A级送风保护 Meet ‘at rest’ conditions of Grade A conditions 满足静态A级条件 ISPE-CCPIE CHINA CONFERENCE 2012 3 Current facility – changes 现有厂房 - 变化 • Aseptic manufacture – iv products 无菌工艺—注射产品 • Unit operations 操作单元 • • • • • Vial filling / Aseptic transfer 西林瓶灌装/转移 Freeze drying – stoppers down in vial 冻干-全压塞 Transfer from FD to Buffer table / conveyer 从冻干机转移至缓冲台 Capping 压盖 Inspection / Packing 灯检/包装 ISPE-CCPIE CHINA CONFERENCE 2012 4 Gap analysis/Risk Assessment 差异分析/风险评估 • Gap analysis and risk assessment conducted for current facility and operations 现有厂房和操作与新版要求间的差异分析和风险评估 • Basis and reference: • • • • China GMP Annex 1 中国GMP附录1 PIC/S Recommendation: PICS建议 • ‘GMP Annex 1 Revision 2008, Interpretation of the most important changes for the manufacture of sterile medicinal products’ • ‘PICS对EUGMP 2008修订版 无菌要求的解释 ’ Bench marking 业界比对 ISPE-CCPIE CHINA CONFERENCE 2012 5 Activity Risk Assessment Mitigation OpenFD door Particle generation/ contamination L •GradeAconditions •AirflowinsideFD-outside •HEPAHEPAairoutside •Asepticoperations =Compliant No 打开冻干 机门 产生颗粒 /引入污染 低 •A级层流 •气流方向由冻干机内部-外 部 •经高效过滤器过滤的空气 •无菌操作=合规 无 Gap analysis/Risk Assessmen