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

DuncanGibbons

Involved In Discussions
#1
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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William55401

Quite Involved in Discussions
#3
Typically (from my experience), there is an exploratory phase outside the scope of validation where you learn what process parameters are important. Orgs have different names for it. Engineering Eval is one. Before you execute OQ, you need to be confident that when you formally explore the corners of your process during OQ (at defined assurance levels), you will succeed. You want to enter OQ and PQ with confidence of success, Evaluations (based on DOE principles) that gather this information gets you there. Running OQ (or PQ) based on hope is not a recipe for success. Defending validations that had failures and re-execution is no fun. Your goal (coming from a compliance professional who consults on consent decrees, warning letters, 483), is to have clean boring validation packages. Product Development has a phased approach. Think of Validation in a similar manner. Often, you will need to explore the process to gain the confidence to formally execute OQ at the corners and replicate PQ at the center points. Sure, there are cases like replicate equipment where Eval may not be needed. HTH. Have fun. Enjoy the ride.
 

chris1price

Trusted Information Resource
#4
Yes, DoE is usually used as part of the OQ (or as William55401 says, prior to the OQ) to determine which parameters have most effect on the outputs. It can also indicate how significant of a change in the parameter will have on the output. However it is not a substitute for performing the PQ which provides the evidence that you can reliably operate within the set limits.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
Screening experiments are used to narrow the large field of input characteristics to a reasonable list of possible important characteristics and they often cant distinguish between main effects and interactions. typically the results of screening experiments is to then run full factorials or other smaller fractional factorials to confirm and further reduce the field to only important characteristics. then a response surface type of experiment or experiments are run to determine the tolerance zones that will provide acceptable results. these are development activities. (of course this is not the only critical characteristics and tolerances are selected.) So running a screening experiment in OQ is way too late.

OQ is intended to validate that you have determined the right input tolerances such that the output is still acceptable at the min/max of the tolerances. it is not a time for development.
 
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