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GMP: European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

17.11.2011
Last year, the European Medicines Agency (EMA) announced in a \"Concept Paper\" that they would revise their Note for Guidance on Process Validation from 2001 and focus on the product lifecycle. The European Compliance Academy together with Concept Heidelberg conducted a survey in September 2011 to find out what the European pharma industry thinks about this approach. In total 509 professionals from industry and authorities provided their input to the survey. It is the most comprehensive survey ever performed on this topic.