Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...
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Why Upper Specification Limits Matter in Process Improvement
What are upper specification limits? During the most recent review of the process control charts, someone noticed that the ...
Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria. "... the number of retests performed before a firm concludes that an unexplained out of ...
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