上海一家企业参数放行理念.pptVIP

参数放行 Parametric Release 参数放行 Parametric Release 上海一家企业参数放行理念 上海一家企业参数放行理念 Parametric Release 参数放行 Introduction 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 上海一家企业参数放行理念 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