2 回答
污染控制策略（CCS）：对微生物，热原和微粒的一系列计划内控制方法，源于对当前产品和工艺的理解，可确保工艺性能和产品质量。
控制可以包括原料，辅料和药品的材料和成分，设施和设备的运行条件，过程控制，成品标准
以及相关的监控方法和频率有关的参数和属性。
Contamination Control Strategy（CCS）-A planned set of controls for microorganisms，pyrogens and particulates，derived from current product and process understanding that assures process performance and product quality.The controls can include parameters and attributes related to active substance，excipient and drug product materials and components，facility and equipment operating conditions，in-process controls，finished product specifications，and the associated methods and frequency of monitoring and control.
