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GMP News No. 788
7 September 2006
EMEA supports PAT for Variations
This document outlines an approach for cooperation between individual EU member states National Competent Authorities (NCAs) for dealing with submitted variations to a product that has been authorised in various member states. With this regulation EMEA intends to simplify the decision process between the involved authorities.
For now the new procedure is limited to variations introducing elements of PAT (Process Analytical Technology) and /or a design space as described in ICH Guideline Q8, where it includes PAT principles.
The new regulations goal is to ensure a harmonised assessment in this relatively new field.
Authorisation holders currently planning variations introducing PAT elements are invited to participate in the pilot phase of this project.
The document shows that European Authorities too consider PAT a quite important issue.
The complete document can be downloaded here:
Analytical Technology (PAT) is the centre of attention at the University
of Heidelberg PAT Conferencein Heidelberg, Germany, from 27-29
Two representatives from European and US Authorities Prof
Christina Graffner (Swedish Medical Products Agency) and Dr Chris Watts
(FDA) will also be present.