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. | 9 METHOD VALIDATION Rosario LoBrutto and Tarun Patel INTRODUCTION 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 Q2B 1 are not yet binding. A more extensive validation full validation is performed for methods used in later stages of drug development after Phase IIa and for methods that will be used to evaluate marketed products. Specific requirements or methodologies for validation depending on the life cycle of the potential drug candidate in each specific area in the drug development process will be addressed in the corresponding chapter. An analytical method is a laboratory procedure that measures an attribute of a raw material drug substance or a drug product. Analytical method validation is the process of demonstrating that an analytical method is reliable and adequate for its intended purpose. Any method that is utilized to determine results during drug substance and formulation development will have to be validated. Reliable data for release of clinical supplies stability and setting shelf life can only be generated with appropriate validated methods. HPLC for Pharmaceutical Scientists Edited by Yuri Kazakevich and Rosario LoBrutto Copyright 2007 by John Wiley Sons Inc. 455 456 METHOD VALIDATION Validation of high-performance liquid chromatography HPLC methods focus mainly on the following Identification tests Quantitative measurements of the content .
