chapter  3
14 Pages

The Role of Designed Experiments in Validation and Process Analytical Technologies

ByLynn D. Torbeck, Ronald C. Branning

Validation and process analytical technology (PAT) require that we find and control the primary sources of product and process variation. Not many people realize that the current good manufacturing practice contain the words validation and variability in the same sentence. “Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product” (1).