上海一家英企业参数放行理念.pptVIP

Parametric Release 参数放行 Introduction 简介 Why Parametric Release? 为何实行参数放行？ Parametric Release Requirements 参数放行的法规要求 Baxter’s Implementation History 百特实施参数放行的历史 The process in China 中国的进展 Introduction 简介 Parametric release is defined as a sterility release procedure based upon effective control, monitoring, and documentation of a validated sterilization process cycle in lieu of release based upon end-product sterility testing. (FDA7132a.13) 参数放行为一种可替代用无菌试验放行最终产品的无菌放行程序。参数放行必须在对经过验证的灭菌循环进行有效控制、监测及文件化管理的基础上实施。 Introduction 简介 Can only be applied to products terminally sterilized in their final containers；Include steam heat, dry heat and Gamma ray sterilization etc. 参数放行仅适用于在最后的包装容器中进行最终灭菌的产品；包括湿热、干热及辐射灭菌等； This presentation will be limited to parametric release as it relates to moist heat sterilization processes. 本处提及的参数放行仅限于湿热灭菌工艺 Why Parametric Release? 为何实行参数放行 （General Definition 基本定义） Sterile release of product based on the achievement of validated process parameters 产品无菌放行应基于所有经过验证的过程参数达到要求 Baxter’s position: Parametric release is the “natural end” to a properly validated process 百特观点：参数放行是工艺过程经过验证的“自然结果” Not dependent on results of sterility test 不依靠无菌检验的结果 Why Parametric Release? 为何实行参数放行？ ( Limitations of Sterility Test 无菌检查的局限性） An inadequate process monitor 一种不充分的过程监测 Statistically limited 统计学局限 Difficult to perform 操作困难 Prone to achieve inaccurate results 易导致不准确的结果 Costly 消耗成本 Why Parametric Release? 为何实行参数放行？ (Limitations of Sterility Test 无菌检查的局限性) Inadequate Process Monitor 不充分的过程监测 10 to 20 product units per batch 每批仅抽取10-20个样品 Successful tests of these tells us little about the level of sterilization in other units in the batch 样品检测合格不能完全代表同批其它产品的无菌水平 Why Parametric Release? 为何实行参数放行？ (Limitations of Sterility Test 无菌检查的