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GMP News No. 507
2 February 2005
Not long ago, EMEA published on its web site an interesting presentation with the title "Regulatory Milestones in EU with Respect to PAT" by Christina Graffner from the Swedish pharmaceutical authority. This publication shows that a number of European documents already contain references to PAT.
The 5th edition of the European Pharmacopoeia mentions e.g. parametric release. Another document referring to this topic is the CPMP's Note for Guidance on Parametric Release (CPMP/QWP/3015/99). Apart from that, there is a separate Annex 17 to the EC GMP Guide dealing exclusively with parametric release.
The European "Note for Guidance on Development Pharmaceutics" (CPMP/QWP/155/96) also contains phrases reflecting PAT's fundamental idea that pharmaceutical manufacturing processes have to be understood ("process understanding").
In November 2003, EMEA formed a PAT Team whose task it is to establish a forum for a harmonised understanding of PAT in the EU - both on the part of assessors in the registration authorities and on the part of inspectors in the supervisory authorities.Author:
Dr Günter Brendelberger