The European Commission has published a proposal for the revision of Chapter 1 Quality Management Systems of the EU-GMP Guide with some comprehensive changes.
The revision had become necessary since the European Commission has to put the contents of ICH Q10 into European legislation. The resulting changes are very comprehensive. This already becomes clear from the title, which was changed from Chapter 1 on "Quality Management" to "Quality Management System" in order to emphasise that the GMP requirements now call for the detailed proof of a system for establishing, maintaining and further developing a quality management system.
Now we would be interested to find out what your thoughts are on the planned revision. For that purpose ECA prepared a brief questionnaire, and we would appreciate it if you took some minutes to fill it in. As usually, you will find the results in the ECA newsletter.
Thank you for your support.
On behalf of the European Compliance Academy (ECA)