灭菌无菌工艺验证指导原则(征求意见稿)创新.docxVIP

 PAGE \* MERGEFORMAT 23 灭菌/无菌工艺验证指导原则（第二稿） 目录  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc363042670 1概述  PAGEREF _Toc363042670 \h 1  HYPERLINK \l _Toc363042671 2制剂湿热灭菌工艺  PAGEREF _Toc363042671 \h 3  HYPERLINK \l _Toc363042672 2.1湿热灭菌工艺的研究  PAGEREF _Toc363042672 \h 3  HYPERLINK \l _Toc363042673 2.1.1 湿热灭菌工艺的确定依据  PAGEREF _Toc363042673 \h 3  HYPERLINK \l _Toc363042674 2.1.2过度杀灭法的工艺研究  PAGEREF _Toc363042674 \h 4  HYPERLINK \l _Toc363042675 2.1.3残存概率法的工艺研究  PAGEREF _Toc363042675 \h 5  HYPERLINK \l _Toc363042676 2.2湿热灭菌工艺的验证  PAGEREF _Toc363042676 \h 6