Per Vase, Managing Consultant, NNE
Louis Meyer, IT Consultant, NNE
In the pharmaceutical industry, the three PQ batch concept is being replaced by continued process verification. However, there is still a validation event (stage 2) prior to going into commercial manufacturing (stage 3). In stage 2 you are supposed to prove future batches will be good and in stage 3 to prove that the validated state is maintained.
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. From version 16, prediction intervals also work with random factors. To live up to the assumptions behind the model, JMP has an excellent toolbox to do the sanity check. The prediction limits obtained in stage 2 can be used as the first set of control limits to be used in stage 3.
A JMP script that combines the necessary tools described above to calculate control limits, prediction limits and process capability in stages 2 and 3 will be demonstrated. The script has been heavily used by many customers. It only requires that data can be described with a model in JMP.
