The ECA Foundation Validation Group's goal is to initiate and facilitate active discussions of current and new regulatory requirements regarding Process Validation and Equipment Qualification. It further aims at identifying and addressing technical issues and challenges and at driving a harmonised approach to common problems and issues. To accomplish its goals, the Validation Group established a European wide networking platform and has been continuously working on discussion and position papers and generic procedures. Now the group announced a change in its leadership team.
The board's chairman, Gert Moelgaard has been leading the Validation Group since 2016 Gert has been working in the pharmaceutical industry since 1982 and has experience from a number of major engineering, automation and validation projects within pharmaceutical manufacturing. Before he founded his own consultancy business Moelgaard Consulting in 2016 he was Vice President Strategic Development in NNE Pharmaplan. He has made international contributions in international conferences on automation, process validation, PAT and manufacturing excellence and has contributed to several books and technical guidelines. Gert now decided to step back as Chairman of the Validation Group, but will remain as a team member.
"We thank Gert for his continued dedication to the group." said Dr Afshin Hosseiny, ECA Foundation Chairman. "During his time, the group has made many valuable contributionson the subject and has initiated discussion on a paradigm change in validation and qualification projects - the group's Integrated Qualification and Validation Guide as version 2.0", recently issued, describes an effective qualification based on a Customer - Supplier Partnership.
Following Gert as new chairman will be Ralf Gengenbach. Ralf is founder and managing director of gempex, a full services provider for implementing, optimising and maintaining quality assurance systems around the world, headquartered in Germany. He is member of several organisations (e.g., ISPE, PDA, SAQ, BAH), president of the supplier association VIP3000 and also was actively engaged in the past in the DIN UA2 (Board for standards 'biotechnology'), and the DECHEMA validation group. He continues to be active as a 3rd party auditor world-wide. "I'm thankful for the time as chair of the ECA's Validation Group, for the support we experienced from the Foundation and the projects we were able to complete." said Gert Moelgaard. "But I'm also happy that Ralf accepted to further lead and develop the group, and I wish him best of luck for it."
Learn more about the ECA Validation Group's goals.
About the ECA Foundation Validation Interest Group
Validation has been one of the most important topics in the GMP environment since the 1980s. State of the art is the FDA Guidance for Process Validation from 2011. The FDA favours a Life Cycle Approach with a 3-stage model focused on process knowledge and process understanding. Statistics is also mentioned explicitly. The EU has published a revised Annex 15, which has been valid since 1st October 2015. This Annex goes in the direction of the FDA and emphasizes a life cycle approach. Harmonisation aspects were one reason for the Annex 15 revision. However, there are still some differences between the US and the EU approach, and therefore, there are some questions to be answered: How do these differences need to be handled? How can a Process Validation Life Cycle be implemented to show process knowledge and process understanding? To facilitate and advance discussions and to find answers, the ECA Foundation established the Interest Group on Validation. To learn more abut this group, please visit www.validation-group.org.
About the ECA Foundation
Founded as an independent not for profit organisation in 1999, the ECA Foundation is Europe's leading association for pharmaceutical Quality Assurance and GMP compliance. Its goal is "the exchange of information between representatives of the industry, regulatory authorities and universities in the field of pharmaceutical quality assurance, especially with regard to the area of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)." For that purpose the organisation has set up several Interest Groups and Working Groups as well as an Academy for advanced education. Individuals can become member of the ECA Groups and in the Academy. In total more than 4.000 professionals have joined the ECA organisation. Its largest group, the European Qualified Person Association, alone counts more than 3.500 QPs. The ECA Foundation Groups developed a range of tools like several Good Practice Guides. For further information on the ECA Foundation please visit www.eca-foundation.org.