I am currently working to validate a process with a supplier. The ask of the supplier was to perform validation. During the OQ, it was asked that non-critical parameters be locked in. Supplier says that they cannot do this, and typically they do not perform OQs. They said they will compromise and run an OQ but will not lock in non-critical parameters.
Typically the supplier runs what they refer to as a pre-qualification prior to each run. Based on the large variability in the raw material, they sometimes need to adjust parameters in order to produce acceptable product.
Questions I have are how does the supplier determine what their critical process parameters are? If they are going to be changing other parameters the affect the output of the process, are these parameters not critical? Does anyone have any experience with this? Is there some way to mitigate the large amount of variability in raw material, in order to validate the process?
Typically the supplier runs what they refer to as a pre-qualification prior to each run. Based on the large variability in the raw material, they sometimes need to adjust parameters in order to produce acceptable product.
Questions I have are how does the supplier determine what their critical process parameters are? If they are going to be changing other parameters the affect the output of the process, are these parameters not critical? Does anyone have any experience with this? Is there some way to mitigate the large amount of variability in raw material, in order to validate the process?