News

The EMA has published together with the FDA a new question & answer (Q&A) paper at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among others it contains the answer to the question "What level of detail should be considered for design of experiments (DOEs) in a regulatory submission?"

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? Which part do the Heads of Production and QA play for the signatures? Read more about the answers provided by the EU GMP Guide.

The publication of the revised draft of the EU GMP Guide's Annex 15 is the opportunity for the EMA to get comments on it. The opportunity has been used by the Austrian QP Associaton (aqpa). Read more about the comments.

With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, movement was brought into the GMP requirements on validation and qualification - also in Europe. Changes attributable to revision of Annex 15 should not be underestimated. The European Compliance Academy (ECA) has carried out a survey and determined how industry assesses these possible changes and which uncertainties exist concerning the revision draft. To get a conclusion on the analysis of the survey read this news.