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.