【原创】无菌药品中污染控制策略（CCS）解读之无菌生产设备管理.docxVIP

【原创】无菌药品中污染控制策略（CCS）解读之无菌生产设备管理 全方位构建污染控制体系，推动科学可行药品污染控制实施工具。 学习通道 扫描右方二维码 即刻报名 （1）EU GMP附录1修订历史 （2）CCS定义 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.? 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。 （3）CCS目的 Quality Assurance is particularly important, and manufacture of sterile products must strictly follow carefully established and validated methods of manufacture and control. A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical?and organisational) and monitoring measures employed to manage risks associated with contamination. The CCS should be actively updated and should drive continuous improvement of the manufacturing and control methods.? 质量保证尤为重要，无菌产品的生产必须严格遵循精心建立，并经过验证的生产和控制方法。 污染控制策略（CCS）应在整个厂房设施内得到实施以确定出所有关键点并评估用于管理污染相关风险的所有控制方式（设计，规程上的，技术和组织层面）和监测措施的有效性。 应积极更新 CCS，CCS 应促使生产和控制方法的持续改进。? （4）CCS的具体实施 The development of the CCS requires thorough technical and process knowledge. Potential sources of contamination are attributable to microbial and cellular debris (e.g. pyrogen, endotoxins) as well as particulate matter (e.g. glass and other visible and sub-visible particulates). Elements to be considered within a documented CCS should include (but are not limited to):? CCS 开发需要全面的技术和工艺知识。潜在的污染源源于微生物及细胞残骸（例如热原/内毒素）以及颗粒（例如玻璃及其他可见和不可见微粒）。文件化的污染控制策略应考虑的要素包含（但不限于）： i. De