Dear Rishabh,

The recently issued FDA Process Validation Guidance recommended multiple specific applications for statistics in the lifecycle approach to process validation. These applications were identified in Stage 1 Process Design, Stage 2 Process Qualification (PQ), and Stage 3 Continued Process Verification. FDA recommendations were quite specific for these respective stages, indicating Agency focus on statistical methods. The guidance described several specific details of statistics applications, including design-of-experiment (DOE) studies in formulation and process development, statistical metrics in PQ, and trending of material, process, and product data in monitoring and maintaining validation.

Product and process scientists and engineers working in development of pharmaceutical products must understand and utilize statistical methods whenever possible. Their work provides the bases for future manufacturing and selection of parameters in pharmaceutical processes. Documentation of their work will be utilized in regulatory submissions, regulatory audits, change control, and other activities supportive to products and processes. The FDA guidance specifically comments on the use of DOE studies to develop process knowledge; reveal relationships, including multivariate interactions; screen variables; and other applications. The guidance mentions applications of DOE in establishing ranges of incoming component quality, equipment parameters, and in-process material quality attributes. Also mentioned are experiments at laboratory or pilot scale that may assist in evaluation of conditions and prediction of process performance. Application of statistical methods are useful in these and associated activities.

http://www.ivtnetwork.com/article/statistical-tools-development-and-control-pharmaceutical-processes-statistics-fda-process-va

Hoping this will be helpful,

Rafik