INTRODUCTION

Documentation can be viewed as the foundation of all quality systems because clear, complete, accurate records are essential to all operations and procedures. This general chapter provides guidelines on good documentation practices for the Good Manufacturing Practice (GMP)-regulated industries, to be used in the production and control of pharmaceutical products, active pharmaceutical ingredients (APIs), excipients, dietary supplements, food ingredients, and medical devices. This chapter describes the underlying principles of proper documentation for GMP operations to assist the user while working with GMP activities. These guidelines should be helpful for building the basic foundation of a quality system that will ensure proper documentation as well as record integrity and control.