I would like getting deeply into Molding Process Validation, I would really appreciate your validation approach.
Molding process is usually a stable validation process at Parameters Window establishment for an equipment/press.
I would like to launch a question to the experts in Molding Process if for Molding Process Validation is necessary to perform an OQ for process parameter window establishment to an existent equipment with an existent validated mold but new parameter window establishment for specific product needs to be redifined.
Regulatory spoken, Engineering Study for establishment new process parameter window with overall 48% of Confidence Level skipping OQ and challeging defined parameters at Low, Nominal and High on a PQ with an overall 90% confidence level, do you think there is a regulatory risk with FDA and regulations?