欧盟对灭菌技术的要求答案.ppt

欧盟对灭菌技术的要求 Sterilisation Technology – EU Regulatory Experiences the compliance group Stan O’Neill CPAPE 2011 年会 Agenda 内容 Background 背景 Typical Process description 典型工艺的描述 Virtual inspection – typical issues 我们来作一次虚拟的检查–看常见的问题 Miscellaneous 其它 Background 背景 Experience in industry in Reg Affairs and QA (as QP) prior to IMB 在进爱尔兰药品管理局前，有制药、法规与QA(QP)的经验 10 Years IMB, experience in most technologies, EMEA IWG, and training. 爱尔兰药品管理局10年，有多种技术、EMEA IWG以及培训方面的经验 Now a “virtual inspector” 现在是“事实上的检查员” So lets do a “virtual inspection” 好，我们来做当一回“检查员” But lets talk about the solutions / strategies / positions; not just the problems. 我们先来讨论战略位置/策略/解决方案，而不只是讨论问题 Typical process 典型工艺 Raw material sampling 原料取样 Materials dispensed 物料配制 Raw materials mixed 原料混合 Bulk product filtered 已过滤的药液 Product filled 已灌装产品 Bulk product stored 药液储存 Units sealed 密封产品 Units stoppered 已加塞产品 Units inspected 已检查品 Quality control 质量控制 Sealed units terminally sterilised 密封产品最终灭菌 Colour coding system 彩色编码系统 Processing steps 操作步骤 Aseptic 无菌操作 Terminally Sterilized 最终灭菌 Problem问题 Solution 解决方案 Ancillary steps 辅助步骤 Processing steps Aseptic Terminally Sterilized Problem Solution Ancillary steps Raw material sampling Identity testing of each container of API and excipients Validated NIR acceptable on each container with MA identity test on composite Classification and garbing for sampling area Grade C (equivalent activity to compounding). No outdoor clothing. Materials dispensed Classification and garbing for dispensing area Grade C (equivalent activity to compounding). No outdoor clothing. Sampling identification 加工步骤 无菌操作 最终灭菌 问题 解决方案 辅助操作 原料取样 对每个容器的原料药与辅料进行鉴别实验 可用经验证的近红外，在生产现场对组份作每个容器的鉴别试验 取样区级别与着装 C级区(与配制活动同级)，不穿室外衣服 物料称量 配料区级别与着装 C级区(与配制活动同级)，不穿室外衣服 原料鉴别 Processing steps Aseptic Terminally Sterilised Problem Solution Ancillary steps Raw materials mixed Bulk product filtered Weeping seal between clean and non-clean side of mixing shaft Understanding the system, ensuring