蒸汽灭菌和冻干工艺的验证及风险分析翻译版.pptxVIP

蒸汽灭菌和冻干工艺的验证及风险分析翻译版;CONTENT 内容;GMP及验证 Qualification Validation lifecycle Risk Management Case studies FMEA of Sterilization Process FMEA of Lyophillization Process FTA of Terminal Sterilized Product Conclusions;GMP 和验证;Extracted from the ROSENHEIM Report 罗森海姆报告有以下内容 The AIR was not properly removed from the chamber 没有适当去除空气 The drain of the chamber was blocked by pieces of glasses 排水管被玻璃堵塞 The lower section of the load did not reach the sterilization temperature 低部位装载未达到灭菌温度 The temperature recorder showed this anomaly but people thought it was not working properly 温度记录有异常，以为是仪表问题 Sterility tests were carried out only on the upper layers of the load 无菌检查只取了上部的样品;Engineering – Equipment Implications 工程设计-设备方面;21 CFR parts 210-211 (211.100, 211.110, 211.213) 联邦法规210-211 (211.100, 211.110, 211.213) 21 CFR part 820 (820.75) 联邦法规820 (820.75) EU – GMP (Cap. 5.21 – 5.24) 欧盟-GMP (Cap. 5.21 – 5.24) EU – GMP Annex 15: (Qualification and Validation) 欧盟-GMP (Cap. 5.21 – 5.24) 确认与验证 Compliance Policy Guide Sec. 490.100 (Process Validation Requirements for Drug Products Subject to Pre-Market Approval) 达标方针指南 490.100 节 （药品批准前工艺验证要求）;EU GMP 5.21: Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures. Results and conclusions should be recorded. 验证试验应强化GMP并按规程进行。应有记录和结论 Annex 15 EU GMP Principle: 欧盟GMP原则 It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation. GMP要求生产企业鉴别需要验证的内容，以证明特殊操作的关键点受控。影响产品质量的厂房、设备及工艺的重要变更均应验证。应通过风险评估确定验证的范围。;验证;?Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meetin