From the ECA: The GMP Questions & Answers Guide

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The European Compliance Academy has recently published (April 2014), The GMP Questions & Answers Guide, an incredible resource for API and drug product questions. This is a compilation of GMP questions and answers from regulators around the world, like, EMA, MHRA, FDA, Health Canada, and TGA.   Some of the topics covered include cross contamination, quality by design, quality management, risk assessment, and stability. The intent is for ECA to update this collection periodically.