上海一家企业参数放咬行理念.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