3 February 2009
Delegates Give 3rd QP Forum Good Grades
 The
3rd QP Forum of the European Qualified Person Association (EQPA) was
held in Munich, Germany on 4-5 December 2008 with three parallel
pre-conference workshops on 3 December. One of the workshops was
facilitated by the EQPA's IMP Working Group , discussing topics like the
GMP/GCP interface, the role of the hospital pharmacist in a clinical
trial and minimal requirements for GMP manufacturing for Phase 1
studies. Another workshop was presented by Chris Burgess and Richard
Bonner, both members of the EQPA Advisory Board, addressing important
aspects of the QP in modern pharmaceutical quality systems. Initiated by
the Chairman of the EQPA, Bernd Renger, a 3rd workshop was hosted by the
Plasma Protein Therapeutics Association (PPTA), the primary advocate for
the world's leading source plasma collectors and producers of
plasma-based and recombinant biological therapeutics discussing the
critical areas of working with plasma-based and recombinant biological
therapeutics.
Both the Forum and the pre-conference workshops were rated very positive
by the almost 250 representatives. A survey amongst the delegates
resulted in an overall rating of 1.93 (where 1 was the best rating and 6
the worst). As a result of the feedback given at the 2007 QP Forum in
Berlin, more possibilities for interactions between the QPs were part of
the agenda, like for example, four parallel sessions, longer brakes and
a Q&A session. As this was very much appreciated, it is planned to add
two more parallel sessions for the 2009 QP Forum.
As the year before, Bernd Renger opened the QP Forum with a recent
overview about the status and the activities of the EQPA which currently
has more than 1.100 members and associated members. The EQPA was asked
by EMEA to participate again in the EMEA GMDP IWP Interest Parties
Meeting (November 25th). Martine Tratsaert and Bernd Renger represented
the EQPA. Topic proposals from EQPA were for example the current status
of the QP Discretion Position Paper, Annex 16 and how to avoid
additional responsibilities assigned to the QP in various European
regulations. During the year, the EQPA also carried out surveys amongst
its members and gave feedback to EMEA about topics regarding:
-
the European Commission's Public Consultation in
Preparation of a Legal Proposal to Combat Counterfeit Medicines for
Human Use. Results were submitted to EMEA May 2008 and addressed
some members' concerns.
-
monitoring changes - how does industry ensure that
the actual status of filings or changes of products is monitored and
in compliance when batches are released by a Qualified Person
-submitted to EMEA in September 2008.
The first presentation of the QP Forum given was a shared presentation
of 3 regulating and supervising authorities. John Taylor, Quality and
Standards Manager Acting and Group Manager, Enforcement and Intelligence
of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA),
Zofia Ulz, Main Pharmaceutical Inspector at the Main Pharmaceutical
Inspectorate in Poland and Rudolf Völler, Director of the GMP
Inspections Department of the local authorities in Darmstadt, Germany
gave an overview of inspection findings with QP relevance made by their
inspectorates. Based on selected examples and case studies, compliance
challenges for QPs were presented and evaluated.
Another presentation was given by Jenneke de Goeij, talking about how
the QP can use Risk Management in the daily operations and how
risk-based decisions can be made and documented.
EMEA's Karin Nodop (from Inspection Sector at the European Medicines
Agency) gave her view on the QP's role and responsibility in the EU
Legislation and GMP for APIs and Excipients with a focus on the
qualification of suppliers. Her presentation was completed by a short
quiz where the delegates could test their know-how based on complex
examples - an interaction which was very much appreciated by the
delegates.
"Batch C234HR is low in assay but it must be released today!", "This is
a very expensive product!"; doesn't that sound familiar? The QP in
conflict was the topic of Afshin Hosseiny's presentation. He gave
valuable hints on how to handle instruction to release non-conforming
material, recourse management and liability and indemnity.
Richard Bonner and Rudolf Völler were then talking in a shared
industry/authority presentation about contract services and the QP's
responsibilities and challenges with suppliers, service providers, TPMs
and Contract Laboratories. Topics like virtual companies and contract
QPs are always good for lively discussions, as also seen at the
subsequent Q&A session.
During this Q&A Session more than 40 questions asked by the delegates
were answered by the speakers team. A lot of them were addressed
directly to Katrin Nodop from EMEA who gave very valuable information at
first hand.
 Again very much appreciated was the social event on Thursday evening.
Four busses with well selected guides took the QPs for an interesting
sightseeing tour through Munich, the famous capital of Bavaria. Followed
by a dinner in a traditional restaurant right in the city centre, the
participants were able to continue their discussions and share their
experiences with their colleagues in a relaxed atmosphere.
The 2009 QP Forum will be held in Barcelona, Spain on 3-4 December with
three pre-conference workshops on the 2 December. At the EQPA Advisory
Board on 22 January 2009 in Frankfurt, a structure was defined and first
presentations and parallel sessions identified. We will keep you
informed.
Author:
Wolfgang Schmitt
On behalf of the Europan QP Association
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