what is new with annex 16
New Concept paper on Annex 16 of the EU-GMP Guide. The European Medicines Agency (EMA) has published a Concept paper on revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release.ince that time, the pharmaceutical environment has been changing and new technologies like, for example, PAT and Real Time Release Testing have been developed. And the implementation of ICH Q8, Q9 and Q10 is having a huge impact on pharmaceutical quality management systems.