1. INTRODUCTION

This general information chapter provides guidelines for methods, facilities, and manufacturing controls recommended for use in the production of pharmaceutical excipients in order to ensure that excipients possess the quality, purity (i.e., consistent composition), safety, and suitability for the use that they purport to possess. The principles and information in this chapter can be applied to the manufacture of all pharmaceutical excipients [referred to throughout this document as excipient(s)] intended for use in human and veterinary drug products, including biologic drug products. This chapter covers the quality management system (QMS) and the extent of good manufacturing practices (GMPs) necessary throughout manufacturing for both batch and continuous processes.