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The European Commission’s revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products will have implications for pharmaceutical companies that market their sterile drug products in the EU, whether manufactured in the US or elsewhere in the world. The changes, which focus on contamination control and sterile processing technologies, mean there is likely to be an increase in demand for plug and play, single use solutions that enable manufacturers to meet the new requirements with minimal effort.