Simplifying Global Compliance
EMA’s EudraLex Volume 4 Offers Inspection Guidance
Executive Briefing Series
When the European Medicines Agency (EMA) established EudraLex in 1998, it borrowed language from many sources, including the International Organization for Standardization, FDA good manufacturing practices (GMPs), 21 CFR Part 211 and International Conference on Harmonisation (ICH) Q7A.
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