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Qualified Person Education Course Module B PLUS pre-course Session: “Interpersonal and Soft Skills for the QP”

18-20 June 2024
Barcelona, Spain


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QP Forum

European QP Association's First QP Forum well Received

From 30 November – 01 December 2006, the first QP Forum of the new European QP Association was held in Prague, Czech Republic. 150 Delegates from 26 countries were present – almost all of them QPs. And all of them came to Prague to be part of the foundation of the QP Association.

In his preamble as the association's first chairman, Dr Bernd Renger, Director Quality Control at Vetter Pharma-Fertigung GmbH, Germany, explained the short but successful history of the QP Association and its ideas and goals.

Goal of the first meeting was to establish a platform for sharing experience and discussing the critical areas of the QP's daily work. Representatives from EMEA and national authorities as well as QPs were invited to share their view of roles and responsibilities of the Qualified Person.

David J. Cockburn from the EMEA, U.K., who felt honoured to give the opening presentation, called the foundation and the QP Forum a "landmark event", before giving his detailed overview on the Qualified Person within the European legislative framework. He presented relevant legislation and guidelines and described in detail how new and future developments could affect the role and the work of the Qualified Person.

Dr Renger shared his views about batch releases in the case of OOS results and deviations – a presentation which led to an interesting and fruitful discussion that also emphasised the need for better guidance.

The latest draft of the QP Association Good Practice Guide was also presented, and more input was requested to advance it. Richard Bonner completed this part with an overview of the U.K. Code of Practice.

Richard Bonner, Qualified Person and formerly with Eli Lilly and Company (U.K.), gave a presentation about QPs managing the challenge of ensuring GMP-compliant manufacturing of APIs. Discussions also centred on the need of a QP for API manufacturers and on how the Qualified Person of the medicinal product manufacturer can ensure that the API is manufactured in compliance with GMP. Besides knowing the Quality System, the importance of written contracts, clearly defined specifications and a sound change control system was pointed out.

An efficient way on how to audit API manufacturers by third parties was shown by Dr Thomas Buggy of DSM Anti-Infectives B.V., Netherlands, and leader of the APIC Third Party Audit Programme. This programme is getting more and more important to save resources for both the API manufacturer and the contract giver. Details are provided in the brochure which can be found at http://www.apic.cefic.org/publications/publications.html.

Other discussions involved good storage and transportation practice and the QP's responsibilities: GMP does not end at the loading bay. The challenges of the distribution were presented by John Taylor, MHRA, U.K. Legislation doesn't give detailed guidance on this important and often underestimated part of the supply chain. John's lecture comprised expectations as well as a detailed explanation of the risk areas, the appropriate risk assessment and recommendations for how to fulfil the requirements best.

Dr Martin Wesch, a German lawyer specialised in industrial law, hit a topic which is of high interest for every Qualified Person: legal actions against QPs – what can happen and why. Cases of liability and possible sanctions against the QP were presented and Martin gave valuable recommendations.

After a set of parallel sessions with various case studies, Dr Christopher Burgess, QP from the U.K. and an excellent moderator of this event gave an update on current GMP guidelines and the latest development. Focussed on the new ICH documents Q8, Q9, Q10 and recent FDA initiatives, Chris made the delegates aware of new challenges and chances coming with this new guidance. The importance of establishing an integrated quality system and the use of an efficient risk management process were outlined. The presentation was completed with recent EU GMP updates and an explanation of the new FDA OOS Guidance for Industry.

A social event on the evening of the first day of the QP Forum included a guided city tour and enabled participants to network and continue their discussions and share their experience with colleagues from all over Europe in a relaxed atmosphere in a restaurant in the heart of Prague's old town.

In summary, feedback provided clearly demonstrated that the first QP Forum was well received. The attendees' involvement as well as the number and quality of questions asked underlined the importance of the newly formed group. Comments also clearly showed the need for a regular QP Forum to get the latest regulatory updates, to discuss interpretations of guidances and legislation and to learn more about working and acting compliant and efficient.

Author:
Wolfgang Schmitt
On behalf of the European QP Association