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GMP News

IPEC Publishes Version 3 of the Excipient Composition Guide

The International Pharmaceutical Excipients Council (IPEC) published the third version of its Excipient Composition Guide for Pharmaceutical Excipients. The guide provides voluntary best-practice guidance to help manufacturers establish excipient composition profiles and communicate relevant information to users and regulators.

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Inadequate Supplier Oversight and missing Tests: Lessons from an FDA Warning Letter

A recent FDA Warning Letter shows that relying on a supplier's certificate of analysis (CoA) without verifying it can leave patients exposed to toxic contamination. It also shows what adequate supplier qualification and oversight requires.

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Survey Results on the Use of AI in Equipment Qualification

Currently, one of the 'hottest topics' in the GMP environment is the use of Artificial Intelligence (AI). Is it also possible to use AI in the field of equipment qualification? We already surveyed this in 2024. Now two years have passed. What has changed? What is the current view of the use of AI?

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