Manufactureofsterilemedicines–Advancedworkshopfor.pptVIP

World Health Organization Session Outline主要内容 Inspection Findings - Aseptic Processing 检查中发现的缺陷- 无菌工艺产品 Inspection Findings – Terminally sterilised Products 检查中发现的缺陷 – 最终灭菌产品 Questions 提问 Poorly designed processes工艺设计欠佳  Materials transferred into Aseptic area with insufficient sterility assurance物料进入无菌区的程序缺乏无菌保证 Poor transfer of partially stoppered vials to lyophiliser半压塞西林瓶进冻干箱的转移程序不恰当 Excessive holding times for sterile equipment or filtered solutions灭菌设备或过滤后药液的储存时间过长 Poorly designed processes工艺设计欠佳  Single filtration 单级过滤 Filtration not performed as close as practicable to the filling point 过滤操作未尽可能靠近灌装点 Inadequate response to leaking containers – no limits set to prompt an investigation 对产品容器泄漏没有及时反应 – 没有设定启动调查的限度 What happened when these filters are vented!当这些滤器排空时会发生什么情况 Poorly designed processes 工艺设计欠佳 Raw material suppliers not audited but acceptance of side samples e.g. sterile API side samples accepted with no justification 原料供应商没有经过审计，就接受了边缘样品，例如：未经评估就接受了无菌原料药的边缘样品 Prefilled syringe assembly sterilisation sites never audited从未审计预充填注射器配件的灭菌承包商 Poor clean room and aseptic practices不良的洁净区行为和无菌操作行为 Filling needles installed left unprotected while remainder of line set up still taking place Not routinely recorded/documented部分生产线还没有安装完成，灌装针头已安装好而且没有保护，该情况未记录下来 No monitoring during equipment set up 设备安装设置期间没有监控 Allowed interventions into aseptic zone are not derived from risk based process review允许在无菌区域内出现的干扰未经过基于风险分析的工艺评估 Systems/Procedures not clear what to do upon intervention 遇到干扰时的处理系统/程序不明确 Interventions not linked to batch release process 批放行程序没有考虑已发生的干扰 Poor clean room and aseptic practices不良的洁净区行为和无菌操作行为 Interventions not linked to batch release process 批放行程序未考虑已发生的干扰 Excessive numbers of manipulations 动作过多 Excessive numbers of people 人数过多 People routinely located in the class A zone操作人员经常待在A级洁净区 Failure to use isolation and closed techniques 隔离或密闭技术运用失败 Poor clean room and aseptic practices不良的洁净区行为和无菌操作行为 “Any int