清洁验证残留量计算

dengjianyyy

元好问 发表于 2022-6-14 06:19
老师你好，请问这个公式的出处是？以及计算ARL的公式，找了好久没有找到，谢谢

PDA TR29 5.4 Acceptable Total Carryover
5.3就是计算ARL的公式
5.3 Acceptable Concentration of Residue in Next Product
The first determination is the acceptable level (i.e., concentration) of the target residue in the subsequently manufactured product. This may be called by different terms, but for this document that concentration will be called Acceptable Residue Level (abbreviated ARL).

胜贤

瀚霜 发表于 2022-06-07 10:53
划重点，下一产品，下一产品批量越小，单位被污染量就越大呗

说的没错，最大风险控制

来自安卓APP客户端

汤圆草莓馅儿

木木杨1 发表于 2022-6-14 07:26
清洁验证的PDA里面是不是有

《药品生产验证指南》里面有