EU GMP附录1对于CCS进行了明确的定义：
“A planned set of controls for microorganisms, endotoxin/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality.”
“污染控制策略是源于对当前产品和工艺的理解、用于确保工艺性能和产品质量的一系列有计划的措施，这些措施是针对微生物、内毒素/热原和微粒的控制。”
“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.”
“污染控制策略的措施包括原料药、辅料、制剂和其它组分相关的参数与属性、设施和设备操作条件、过程控制、成品标准、以及相关监测控制的方法和频率。”
