无菌工艺验证的建议.pdf

RECOMMENDATION ON THE VALIDATION OF ASEPTIC PROCESSES 无菌工艺验证的建议 © PIC/S January 2011 Reproduction prohibited for commercial purposes.禁止以商业为目的复制 Reproduction for internal use is authorised,内部使用的复制是授权的 provided that the source is acknowledged.提供这来源是公认的 Editor: PIC/S Secretariat e-mail: info@ web site: PI 007-6 - i - 1 January 2011 TABLE OF CONTENTS 目录 1. DOCUMENT HISTORY文件历史 1 2. INTRODUCTION引言 1 2.1 Purpose 目的 1 2.2 Scope范围 1 2.3 General information总体说明 1 3. DEFINITIONS定义 2 4. P