chapter  6
36 Pages

Process Validation

In Chapter 4 we discussed statistical designs and analyses for scaling up a laboratory batch or small-scale production batch to a regular production batch. A scaleup study is conducted to demonstrate that the production batch is equivalent to the laboratory or small-scale production batch often used for product testing prior to manufacture. In Chapter 5 we described requirements for product testing stated in the USP/NF. These requirements are essential to ensure the identity, strength, quality, and purity of the drug product. In this chapter we focus on the validation of a manufacturing process under appropriate statistical designs and analyses according to USP/NF specifications.