关于混合均匀性2阶段测试

5097

1.[Example Sampling Plan] Take at least 3 blend samples from at least 10 locations in the blender
2.Stage 1 Blend Testing: Assay 1 sample from each location and calculate the standard deviation (SD) for the samples
  SD ≤ 3.0% of target, blend uniformity is acceptable; proceed to Stage 1 dosage unit testing
  SD is >3.0% of target, proceed to Stage 2 blend testing
3.Stage 2 Blend Testing: Assay the replicate blend samples from each location and calculate the SD for the samples
  SD ≤ 3.0%, blend uniformity is acceptable; proceed to Stage 1 dosage unit testing. VCA not required
  SD 3.1% - 5.0% (inclusive), blend uniformity is acceptable; proceed to Stage 2 dosage unit testing; recommend performing VCA for the blend and dosage unit data
  SD > 5.0%, conduct an investigation, including VCA
•If the high SD is attributed to a sampling/assay error, proceed to Stage 2 dosage unit testing
•If the high SD is attributed to a product/process related cause, the blend uniformity is unacceptable
在阶段2中是分析每个点的2与3两个样本，一共20个样，计算20个样本的SD吗？还是联同时1阶段的10，共30计算SD？还中只分析2或3共10个样本，再次计算10样本的SD？

蓝海孤叶

告诉你  按1的方式  如果SD>3.0  需要按2的方式操作
标准也是按2的方式
个人理解   所以2阶段结果  应该不考虑1阶段了

yangchb

谢谢分享，学习一下。

wwd7212

不太明白，

lqthjm

谢谢分享！

dghonst

是全部样品计算RSD。另外你这个混样指南已经撤销了。