INTRODUCTION

This chapter provides guidance on the selection, evaluation, and use of microbiological methods as alternatives to compendial methods. To properly implement alternative methods, one must consider a number of important issues before selecting the analytical technology and qualifying that method with the actual product. These issues include, but are not limited to, identification of suitable alternative methodology, development of user specifications for equipment selection, demonstration of the applicability of the method as a replacement for a standard compendial method, and qualification of the method in the laboratory.