On 18 December 2007 the European Medicines Agency (EMEA) has published its work
plan for the GMP/GDP Inspectors Working Group for the year 2008. This document
summarises the planned activities of the respective working group and gives a
comprehensive overview of what the pharmaceutical industry can expect in the
following months. One of the recent developments will focus on Qualification of
Chapter 5 of the GMP Guide will be amended in order to reflect the new
obligations of manufacturing authorisation holders to only use active substances
that have been manufactured in accordance with GMP. Also, a common approach will
be finalised on what is expected from manufacturing authorisation holders with
respect to the assurance of the quality of raw materials used.
The text for public consultation is expected in early 2008.
Besides Chapter 5, also chapter 3, 4 and 5 and the annexes 2, 6, 13 and 14 are
You can find the whole work plan here: