1. INTRODUCTION

Good manufacturing practice requires that test methods used for assessing compliance of pharmaceutical and biological products with quality requirements should meet appropriate standards for accuracy and reliability. Assay validation is the process of demonstrating and documenting that the performance characteristics of a method underlying a procedure are suitable for its intended use. Validation of Compendial Procedures 〈1225〉 describes the procedure validation of physical and chemical methods that measure mass or other physicochemical properties of pharmaceuticals. Biological Assay Validation 〈1033〉 addresses validation of methods that measure biological activity, with the purpose of aligning bioassay performance characteristics with uses of bioassays in practice.