28 February 2008
Review of the QP Education Course in Vienna, 21–22
February 2008
On 21 and 22 February more than 50 QPs, future QPs and
delegates who are interested in the duties and responsibilities of a QP
met in Vienna to hear about and discuss general compulsory and regulatory
issues. The Education Course was compiled by the QP Association Advisory
Board to provide a general idea of the special tasks and responsibilities
of a Qualified Person. In various workshops, case studies were presented
to discuss and convey possible solutions to given problems.
In his opening presentation, Dr Chris Burgess, QP in the U.K. gave an
overview about the legal and professional duties of the Qualified Person.
In descriptive flow charts, the legal background and additional duties
were presented in a comprehensive manner. Guidance was also given with
respect to essential knowledge and practical experience the QP needs to
have.
Lance Smallshaw of Eli Lilly presented a complete overview about the
recent changes in EU legislation. An outlook was given towards growing
GMP-requirements for excipients and the envisaged revisions to EU GMP
Guidelines.
Richard Bonner explained and elaborated the role of the QP in assuring
product quality. It was discussed when and how the QP needs to be involved
in the various steps of the manufacturing process. Questions like:
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Does the QP need to release the API?
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Does the QP need to perform all audits?
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How can the QP assure supplier qualification?
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Who needs to sign the contract?
were addressed. Also, EMEA’s Statement on QP Discretion
on Batch Certification was part of this comprehensive presentation.
In a workshop moderated by Dr Bernd Renger, Chairman of the QP
Association, six real case studies were presented. In small groups the QPs
talked about appropriate actions and release decisions and outlined
possible strategies in case of an inspection.
In Richard Bonner’s workshop on Batch Disposition, the groups discussed
the disposition of a formulated parenteral batch of a live-saving
oncolytic product. Based on the information given, the QPs had to decide
what actions to take.
This first day of the QP Education Course was completed by a very special
social event. Vienna is not only famous for its romantic nostalgia &
modern hype, but also for one of the best movies ever made. The film noir
masterpiece "The Third Man", broaches the issue of fake drugs in post-war
Vienna. Dealers of counterfeited or diluted medicines are no less
unconscionable today than they were decades ago, but meanwhile the
business has grown to a frightening degree. The participants got a picture
of this story during this special event.
Day 2 of the course started with a third workshop. Questions were
elaborated and answered what a QP needs to know about laboratory
operations to ensure correct decision making. This interactive session was
presented by Dr Chris Burgess and Lance Smallshaw. Questions addressed
were for example:
John Taylor, Quality and Standards Manager of the U.K.
Medicines and Healthcare Products Regulatory Agency (MHRA) presented the
possibilities of delegating duties and responsibilities. The role of
contract QPs was also part of this talk – an issue which is getting more
and more into discussion; especially when the QP’s availability at the
manufacturing site is questioned.
Dr Renger’s presentation then further elaborated the role of the QP in
supplier qualification. Topics were regulatory and authority expectations,
audits, assessments, risk based qualification and joint audits to name a
few.
Another area, where the QP is getting more and more involved, is the
pharmaceutical supply chain. Storage and transportation compliance issues
and concerns were presented by John Taylor and possibilities how to face
these challenges were discussed.
How to face regulatory inspections and current inspection hot topics were
then introduced by Richard Bonner in the last session of this QP Education
Course.
This successful event will be repeated in Berlin, Germany, on 1-2 October
2008.
Author:
Wolfgang Schmitt
On behalf of the European QP Association
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