Many of the principles in this general information chapter are derived from an international guidance on the extent and point of application of appropriate good manufacturing practice principles. It is intended to assist excipient manufacturers in determining whether the methods used in, and the facilities and manufacturing controls used for, production adequately ensure that an excipient possesses the quality, purity, safety, and suitability for use that it purports to possess.

The principles and information in this chapter can be applied to the manufacture of all bulk pharmaceutical excipients (referred to throughout this document as “excipient(s)”) intended for use in human drugs, veterinary drugs, and biologics. It covers the quality systems and the extent of good manufacturing practices necessary throughout the chain of production up to and including delivery to customers. As an international guidance document, it does not provide information for all national legal requirements nor cover in detail the particular characteristics of every excipient. The quality system standard used as a framework for this chapter is ISO 9002, which is appropriate to manufacturing. Information specific to excipients has been added. Because of the diversity of excipients, some principles in this information chapter may not be applicable to certain products and processes.

This information chapter combines existing governmental regulatory good manufacturing practices principles and international quality management system requirements as developed by The International Organization for Standardization (ISO). In view of the increasing globalization of the pharmaceutical industry and the harmonization of pharmaceutical registration requirements, deference to both schemes is becoming necessary. Therefore, relevant portions of both manufacturing concepts are employed throughout this chapter.

The General Guidance section provides an overview of the appropriate manufacturing practices criteria applicable to excipient manufacture and the point of application of excipient good manufacturing practices and quality systems. This section also recommends measures to limit contamination of an excipient and provides the relationship of excipients to finished dosage forms. For a list of terms and their definitions used in this information chapter, see Appendix 1. The section Excipient Quality Systems provides information on the requirements necessary for compliance with relevant good manufacturing practice principles and implementation of an excipient quality system. Information for production facility requirements are included under Process Control. No attempt has been made to include details specific to particular excipients. The information under Appendix 2, General Auditing Considerations, sets forth key criteria to aid in the audit of an excipient manufacturing facility.