The EU GMP Guide Annex 15 was originally published in 2001. At the end of October 2012, the EU has announced to revise it. Now the draft for the revision of Annex 15 is published. All in all there is an abundance of new requirements. Some new terms ar a bit "nebulous" and the whole document seems to be a little "spongy". Therefore, the ECA has set up a survey to get a feedback from the pharmaceutical industry. A summary of the feedback will be forwarded to the EU Commission and will also be published as news. Read more.