PDA TR咨询

飞鸟集

想问下PDA TR技术报告总共有多少章节，为什么大家发的都没有PDA TR-02、06、37呢？

有希望呢

TR2 和TR6已经被TR22（1996）的取代了，所以没有这两个技术报告，
TR22（1996）中的原文如下：
“This document replaces the previous PDA technical documents on the validation of aseptic processing: Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products, 1980; and Technical Report No. 6, Validation of Aseptic Drug Powder Filling Processes, 1984. Our intent in this effort was to update these documents and expand the coverage to other dosage forms, as well as embrace the changing nature of aseptic processing technology within the global industry. We have attempted to address the subject as fully as possible, recognizing the notable contributions by other organizations, regulators, compendia and individuals who have worked in this area.”

lzq050628

每年都有更新，目前最新的是TR88，那几个，搜一下就能找到

椒陵小小兵

你去PDA官网看下就行了

classicboy

PDA TR6 无菌粉末灌装过程验证，很老的文件了。

PDA TR2、37的确没见过。

晴天°皓月

有些都没发布过

小金库

感谢分享，努力学习