In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...
The author argues that traditional concerns about repeatability and intermediate precision remain valid but insufficient. The US Pharmacopeia is replacing its current Chapter <111> "Design and ...
Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen. Validation failures, just like out-of-specification (OOS) ...
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