INTRODUCTION

A large variety of analytical instruments, ranging from a simple apparatus to complex computerized systems, is used in the pharmaceutical industry to acquire data that will help ensure that products meet their specifications. Many of these instruments combine a metrological function with software control. There are many ways of demonstrating that an instrument is qualified and under control, and these can include qualification, calibration, validation, and maintenance. In order to ensure “fitness for purpose”, an integrated approach, based upon a risk assessment, is recommended. For the purposes of this chapter, the term “instrument” includes any apparatus, equipment, instrument, or instrument system used in pharmacopeial analyses.