BACKGROUND

This general information chapter provides guidelines for methods, facilities, and manufacturing controls to be used in the production of pharmaceutical excipients in order to ensure that excipients possess the quality, purity, safety, and suitability for 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 drugs, veterinary drugs, and biologics. It covers the quality management system and the extent of good manufacturing practices (GMP) necessary throughout manufacturing for both batch and continuous processes. It is intended to assist manufacturers as well as auditors in establishing whether the facilities and controls used for the manufacture of excipients are adequate and whether the excipients possess the quality and purity that they purport to possess and are suitable for their intended use. The manufacture of certain excipients for specialist applications presents additional challenges that are outside the scope of this chapter. Examples include excipients for parenteral, ocular, inhalation, and open wound use and those that are sterile and/or pyrogen-free. It does not provide information for all national legal requirements nor does it cover in detail the particular characteristics of every excipient. The quality system standard used as a framework for this chapter is ISO 9001, which is appropriate to manufacturing. Because of the diversity of excipients, some principles in this information chapter may not be applicable to certain products and processes.