关于OSD的环境设置的问题

beiwei5du

4.1.1 Brief description of the air conditioning system
All areas for openly handling raw materials and/or products are qualified with reference to clean room class D (RKD) The secondary packaging takes place in clean room class E (RKE).
No room classes are defined in the EU-GMP guidelines for manufacturing non-sterile solid forms; so it is an individual decision by Maas & Peither Pharma GmbH to carry out production in rooms of a similar class to clean room D. Here "similar" means that the ventilation system is designed to comply with the particle limit values stated for this clean room class in Annex 1 of the EU-GMP guidelines but other limit values and intervals have been established for microbiological and particle monitoring.


其实在国外，没有对于非无菌固体制剂的暴露环境进行相应的环境级别硬性要求（比如必须在D级或D级以上等等），所以以前WHO的非无菌固体制剂的指南中提及到相应的class E,class D的概念。按照该上述原文，完全可以基于RA的结果，设置similar CLASS X（即particle limit符合相应的EU-GMP annex/ISO class的要求，而微生物限度等则采用自定义的限度标准）

beiwei5du

论坛版主，发现帖子中的字体颜色存在bug呢，请及时解决（比如在编@意林枫 辑的时候是一种颜色，最后发送确认后是另一种颜色）@蒲公英

冷血无情

beiwei5du 发表于 2016-10-18 07:40
论坛版主，发现帖子中的字体颜色存在bug呢，请及时解决（比如在编@意林枫 辑的时候是一种颜色，最后发送确 ...

这个好像应该@豚鼠

北重楼

beiwei5du 发表于 2016-10-18 07:40
论坛版主，发现帖子中的字体颜色存在bug呢，请及时解决（比如在编@意林枫 辑的时候是一种颜色，最后发送确 ...

这个你发帖的时候可以自己设定呀

beiwei5du

fyi