IPEC Federation published an updated version of its position paper “Pharmaceutical Excipients GMP Documents Supported by the IPEC Federation”, firstly issued in 2020 to help excipient manufacturers navigate the evolving landscape of Good Manufacturing Practice (GMP) requirements.

The paper explains the purpose of three key GMP documents and how they may be applied, supporting manufacturers in making informed decisions on which document best suits their operations.

It provides an overview of the Joint IPEC–PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, the EXCiPACT™ GMP Annex, and the NSF/IPEC/ANSI 363 Excipient GMP Standard, along with practical questions to guide the selection.

IPEC Federation emphasizes that all three documents are essential for implementing excipient GMPs within a manufacturer’s Quality Management System. Manufacturers should clearly communicate which document they follow to ensure transparency for both customers and auditors.

The document is available on the IPEC Federation website.