APIC清洁验证指南疑问

beiwei5du

4.2.4 General Limit as acceptance criteria
If MACO calculations result in unacceptably high or irrelevant carryover figures, or toxicological data for intermediates are not known, the approach of a general limit may be suitable. Companies may choose to have such an upper limit as a policy. The general limit is often set as an upper limit for the maximum concentration (MAXCONC) of a contaminating substance in a subsequent batch.
Procedure
Establish MACOppm, based on a general limit, using the following equations.
MACOppm = MAXCONC x MBS
MACOppm Maximum Allowable Carryover: acceptable transferred amount from the investigated product (“previous”). Calculated from general ppm limit.
MAXCONC General limit for maximum allowed concentration (kg/kg or ppm) of “previous” substance in the next batch.


hi各位，看到APIC清洁验证指南中，MAXCONC单位kg/kg是否不正确呢？？是否应该改成mg/kg???????@hongwei2000 @谢大侠来了

beiwei5du

4.2.4 General Limit as acceptance criteria 可接受标准的一般限度
If MACO calculations result in unacceptably high or irrelevant carryover figures, or toxicological data for intermediates are not known, the approach of a general limit may be suitable. Companies may choose to have such an upper limit as a policy. The general limit is often set as an upper limit for the maximum concentration (MAXCONC) of a contaminating substance in a subsequent batch.

如果 MACO计算得出的残留量太高或者无关联性，或中间体毒性数据未知，则适用通用限度方法。公司可以选择例如一个最高限度作为原则。通用限度一般设定为一种污染物质在后续批次中最大浓度上限（MAXCONC）。

使用基于ADE，基于日治疗剂量和基于LD50算出的结果，在什么情况下判定为unacceptable high和irrevlevant？？？？是按照APIC中说的
注：ICH 杂质文件（Q3）指出，在被测试的产品中，单个未知杂质可以达0.1%，总未知杂质可以达到0.5%，
是指按照前三种方法超过原料药的杂质限度时，才采用通用标准5-500ppm？

hongwei2000

mg/kg不就是ppm了
kg/kg意思是重量百分比
只要你带着单位都不会错

beiwei5du

hongwei2000 发表于 2015-5-29 08:32
mg/kg不就是ppm了
kg/kg意思是重量百分比
只要你带着单位都不会错

确实在最近2017.01cleaningvalidaition针对于APIC(2016.09)评论文章中说到这个问题，可能是一个打印错误（typo），但是2014.06月出错，最近2016.09版也出错，实在是对celfic APIC这样的官方组织不应该啊！

DK1024

ANNEX1中，例1ADE的计算为什么没有乘以体重啊？但是例2乘以了体重

我知道了，我才发现单位不一样