欧盟 GMP 对于制药用水系统的要求
• Water treatment plants and distribution
systems should be designed, constructed
and maintained so as to ensure a reliable
source of water of an appropriate quality.
They should not be operated beyond their
designed capacity. Water for injections
should be produced, stored and distributed
in a manner which prevents microbial
growth, for example by constant circulation
at a temperature above 70°C.
• 水处理设施及其分配系统的设计、安装和维护应
能确保供水达到适当的质量标准。水系统的运行不
应超越设计能力。注射用水的生产、贮存和分配方
式应能 防止微生物生长,例如在 70℃ 以上保持循
环