PDA_TR28 中英 无菌原料药工艺模拟验证(2006年).docVIP

无菌原料药（BPCs）的工艺模拟 PDA第28份技术报告（2006年） This document provides guidance relative to the validation of aseptic processing activities associated with the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts and principles developed in PDAs and PhRMAs prior publications on aseptic processing technology (1, 2, 3). This effort expands upon those documents to provide assistance for individuals and firms producing sterile bulk pharmaceutical chemicals. Our goal in this revision was to update the document to reflect 6 years of industry experience with it, as well as an acknowled