IPEC-Americas Publishes Good Manufacturing Practices (NSF/IPEC/ANSI 363) Audit Guide for Pharmaceutical Excipients

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Friday, January 20, 2023

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) announces the availability of an IPEC-Americas Good Manufacturing Practices (NSF/IPEC/ANSI 363) Audit Guide for Pharmaceutical Excipients.

This Audit Guide covers aspects of good manufacturing practices associated with excipient manufacture and was designed to assist users in evaluating excipient manufacturing practices and quality systems. It can also be used as a helpful reference to assist excipient manufacturers in meeting appropriate cGMP requirements to assure consistent product quality.  It is intended to have international application, bearing in mind that pharmaceutical excipient production covers a diverse range of different industries and processes whose products often have uses other than pharmaceutical applications.

This Audit Guide is provided in two formats, either of which may be used by the auditor based on personal preference:

• Detailed questions arranged in the same ANSI Standard sequence. This format is frequently useful as a personnel training tool for the auditing company and company being audited;

• Short "reminder" phrases arranged in the same ANSI Standard sequence, a format which generally is more useful during audits.

IPEC-Americas unique combination of experts from excipient makers, distributors and users makes this association uniquely positioned to understand the underlying risks to excipient quality. IPEC-Americas mission is to ensure that excipients meet the highest appropriate standards for quality, safety and functionality throughout their manufacturing process and supply chain.

The Guide is available for download in the Document Depot at no charge to IPEC-Americas members and non-members (after registering) by visiting www.ipecamericas.org.

About IPEC-Americas

IPEC-Americas is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with its counterparts in Europe, China, Japan, and India serves as a primary international resource on excipients for its members, governments, and public audiences.

Register Now for the January, 25 webinar: How to Use the 2023 IPEC-Americas Audit Guide in Conjunction with the NSF/IPEC/ANSI 363 Excipient GMP Standard

For additional information and technical inquiries in the U.S., contact: ipecamer@ipecamericas.org