HPLC for Pharmaceutical Scientists 2007 (Part 9)

The method validation process is to confirm that the method is suited for its intended purpose. Although the requirements of validation have been clearly documented by regulatory authorities [ICH, USP, and FDA], the approach to validation is varied and open to interpretation. Validation requirements differ during the development process of pharmaceuticals. The method validation methodologies in this chapter will focus on the method requirements for preliminary and full validation for both drug substance and drug product. Preliminary method validation is generally performed in the earlier phases of development up to Phase IIa because at this time ICH Q2A and...