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
CONCEPT HEIDELBERGSource:
This presentation can be found on EMEA's Process
Analytical Technology web page or it can be downloaded directly via this
link.
