Per Vase, Managing Consultant, NNE
Louis Meyer, IT consultant, NNE
The three PQ batch concept in the pharmaceutical industry is being replaced by continued process verification. However, there is still a validation event (stage 2) before going into commercial manufacturing (stage 3). In stage 2, you are supposed to prove future batches will be good, and in stage 3, you are to prove that the validated state is maintained. If this can be done, there is no need for end-product testing any longer leading to large QC cost reductions. JMP has the ideal toolbox for both stages. If the process can be described with a model, prediction intervals with batch as a random factor can be used to predict the performance of future batches. To live up to the assumptions behind the model, JMP has an excellent toolbox to do the sanity check. Even cases with variance heterogeneity can be handled through weighted regression. A JMP script that combines the necessary tools described above to calculate control limits, prediction limits, and process capability in stages 2 & 3 will be demonstrated. The script has been heavily used by many of our customers. It only requires that data can be described with a model in JMP.
