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LOGFILE No. 18 / J une 2014 Maas & Peither AG GMP Publishing

http://www.gmp-publishing.com
2014 Maas & Peither AG GMP Publishing, Schopfheim, Germany, All rights reserved page 4

Tor Graberg made it clear that the terms trust, collaboration and communication are inseparably
intertwined with knowledge management. It is not new requirements or standard procedures
that the authorities wish to set up. What they do want, however, is to heighten awareness of the
fact that the pharmaceutical industry will not master future challenges without appropriate
knowledge management.

Workshops
Since the event was conceived as a workshop, six discussion groups were worked into the agen-
da. In many hours of work they developed a fundamental understanding based on the talks
presented. The topics ranged from IT tools to following organisational changes in companies.
The necessity of cultural change and raising levels of awareness became apparent in the course
of many discussions. It was a very open exchange and the participants returned to their various
companies with a great deal of knowledge to share with their fellow employees.
The draft revised version of Annex 16 was open for public consultation until the end of Novem-
ber 2013. The rapporteur of the GMP/GDP IWG (the Finnish regulatory agency FIMEA) is in the
process of reviewing comments received and developing a consolidated version together with
the drafting group. Publication of the final version will foreseeably take place in the course of
this year.
Annex 16 now takes the global supply chain into account and deals with implementation of new
control strategies for quality. Of primary importance here are detailed requirements for the
Qualified Person (QP), reliance on third-party GMP verification and handling unplanned devia-
tions.

Summary
The workshop as a whole was a great success and the Task Force Knowledge Management in
Manufacturing Organisations gained much insight that will be useful for upcoming work. It will
be exciting to see how this subject continues to develop.


Links:
LOGFILE 04/2011
LOGFILE 05/2012
www.apqc.org


Author:
Thomas Peither
Peither & Consultants GmbH
Karlstr. 2, 79650 Schopfheim, Germany
E-mail: service@peither.com