Analytical Procedure Lifecycle USP <1220> general chapter: Automate the calculations and visualise the results using JMP
Feb 22, 2018 9:08 AM
check if IP and bias meet ATP requirements.jmp
optimise calibration format.jmp
precision reportable value.jmp
Analytical method development and validation in the pharmaceutical industry is currently evolving with more emphasis now being placed on understanding the measurement error in an effort to ensure methods of analysis are fit for purpose. The USP Validation and Verification Expert Panel recently published a new draft general chapter <1220> “The Analytical Procedure Lifecycle”. Several stimuli articles were also published providing details of calculations proposed to support the development and qualification of analytical methods, including:
Using misclassification rates to establish the Target Measurement Uncertainty.
Optimisation of the precision of the reportable value and calibration format.
Verifying that the analytical procedure meets the Analytical Target Profile.
These calculations represent a significant step change compared with what has traditionally been performed, and to ensure adoption of these new concepts, it will be important for analytical scientists to have access to easy-to-use tools which can process the results and visualise the outcome.
This poster looks at some of the calculations and graphs detailed in these stimuli articles and show how they can easily be performed, automated and visualised in JMP with the use of scripts.