News about GMP/cGMP

29.06.2018

EU GMP Guidelines in Progress

On 26 and 27 June 2018, the PDA Europe Annual Meeting took place in Berlin. Thomas Peither, Excecutive Editor and President of Maas & Peiter AG, participated in the conference and brought back interesting insights.

One of them was an interesting overview on current EMA activities, presented by Roberto Conocchia, European Medicines Agency (EMA) and former GMP inspector in Italy. It shows a range of GMP guidelines which will be updated soon.

The IWG is currently working on the finalisation of Annex 1. An impressive number of 6200 lines of comments addressed to the document have to be worked through. This work should be finished by December 2018. A publication is expected for March 2019.

UPDATE***NEW***UPDATE

Annex 17 on Real Time Release Testing and Annex 2 on Biological Substances have meanwhile been finalised and published by the European Commission.