共线风险评估概述.pptVIP

共线风险评估;;为什么不共线;共线与专线的主要考虑‐‐‐交叉污染;Risk Management风险管理 ;第一步：从工艺/产品A中释放污染物到环境中;第一步：从工艺/产品A中释放污染物到环境中;;ISPE (Risk‐MaPP);FDA 对交叉污染控制的期望;Can be controlled by understanding the sources and nature of the potential adventitious agents or hazards能通过理解外来物质或危险物质的来源和属性来控制 ? Involves risk management涉及到了风险管理 –Where hazards are identified, controls must be multi‐dimensional，Commensurate with risks危害识别后，控制应该是和风险适应的多维度的 Actions to control cross contamination may include控制活动包括 ? Managing opportunities for the spread or carryover of cross contaminants管理交叉污染的传播或负载的机会 ? Reducing carryover to acceptable levels where