Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach

DuncanGibbons

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Hi all,

With Operational Qualification being the understanding and characterizing process limits (worst-case scenarios) and parameters, and Performance Qualification being ensuring the reliability of the process remains within these characterized parameters and limits. From my limited understanding, DoE can be used at the OQ phase to determine which parameters are of importance but does it also ensure reliable processes as per the PQ phase or not? Additionally, are screening experiments a method that falls under the DoE principle?

Thanks,
Duncan
 
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