In a “Concept Paper” from 2010 the European Medicines Agency (EMA) announced that they would revise their Note for Guidance on Process Validation from 2001. This revision’s goal is to implement modern aspects (“enhanced approach”) to move towards a “continuous process verification.
To find out what the industry thinks about this approach, the European Compliance Academy (ECA) conducted a survey in September 2011. More than 500 professionals provided their input to the survey. The results were mailed to the EU Commission and the EMA. Here you will find this letter summarising the survey results.