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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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ICH publishes Online Training Materials for ICH E6(R3) Good Clinical Practice

The International Council for Harmonisation (ICH) has expanded its training library with new training materials for the ICH E6(R3) Good Clinical Practice (GCP) guideline. Read more in our news article.

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EDQM Updates Guidance on CEP Sister File Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a revised version of its guidance on applications for "sister files": PA PH CEP (09) 141. Its purpose is to improve the consistent interpretation and application of the procedure, while providing applicants with greater clarity on eligibility, documentation and assessment expectations.

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