GMP: The new EU GMP Chapter 1 in Pharmaceutical Development

The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called \"Pharmaceutical Quality System\". Chapter 1 was amended in order to align with the concepts and terminology described in the ICH Q10 tripartite guideline on Pharmaceutical Quality System and includes comprehensive changes.