Level: Intermediate Per Vase, Managing Partner, Applied Statistics Group, NNE
Many companies within the pharmaceutical industry still pass a Process Performance Qualification (PPQ) simply on the fact that the estimated Ppk on three consecutive batches are better than the acceptance criteria. However, validation is about predicting the future – NOT the past. So even though the three batches may have a sufficient Ppk, this is not sufficient. The prediction for future Ppk values also needs to look promising. The International Society of Pharmaceutical Engineering (ISPE) has published a discussion paper, Evaluation of Impact of Statistical Tools on PPQ Outcomes, on how this prediction can be made from a variance component calculation of between- and within-batch variance converted to process capability indices. One of the reasons this method has not become widespread is the lack of statistical software packages with this calculation method as a standard. However, with the three-way chart in JMP 14, you can now calculate the between- and within-Sigma capability. Examples where this method has been used for PPQ evaluation will be shown in JMP 14, both with successful and unsuccessful evaluations. It will be compared with the traditional method mentioned previously.