This general information chapter is based on the Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients (2001), prepared by The International Pharmaceutical Excipients Council of the Americas (IPECamericas). 

On the basis of the results of a comprehensive gap analysis of the current USP 1078 that utilized several US and international good manufacturing practices (GMPs), including IPEC-PQG Excipient (2017), NSF/IPEC/ANSI 363, EXCiPACT 2021, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7—Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, and GMP guidelines from China, Brazil, and Mexico, the Excipient Test Methods Expert Committee recommends to revise this chapter. 

This revision provides a harmonized and comprehensive set of criteria for the quality management systems (QMS) used in the manufacture of pharmaceutical excipients worldwide. Additionally, a concept of risk management and risk assessment that will guide excipient manufacturers in making decisions regarding suitable application of GMP based on the level of impact on the quality of the final excipient and drug product is introduced. Revisions have also been made to the Glossary to reflect changes to the chapter.

Changes have been made to the Appendix to align with those drafted for the updated auditing guidelines developed by IPEC.

This chapter it is intended to aid both auditors and manufacturers in establishing whether the facilities, equipment, and controls used for the manufacture of excipients are adequate.

GMP conformance should help ensure consistent excipient composition.

Detailed information pertaining to the intended use of an excipient as marketed by the excipient manufacturer or provided by the end user to the excipient supplier and application of risk management principles, can be useful in implementing GMPs. 

Monographs or appropriate specifications provide for safe excipients of acceptable quality.

If the appropriate quality standards are not implemented and followed, excipients may pose a hazard to patient safety.

Thus, the requirement to have a robust QMS in place that assures the quality of excipients remains imperative, particularly as adulteration of pharmaceutical excipient purity has resulted in many human tragedies.

Some principles in this information chapter may not be applicable to the manufacture of certain excipients because of the diversity of excipients and manufacturing processes.

Where appropriate, application, and/or non-application, of the principles in this chapter should be justified in a documented risk assessment.

Resource Person: Barbara Pirola