Ralf Gengenbach becomes Chairman of the ECA Validation Group
What will determine the validation of tomorrow?
The ECA Foundation is the leading European association for pharmaceutical quality assurance and GMP compliance. Its goal is the exchange of information between industry, regulatory authorities and universities, especially with regard to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). To this end, the organization has established interest and working groups, set up an academy for further education, and developed tools and guides for Good Practice. More than 4,000 professionals are affiliated with the ECA organization.
Now the ECA announced a change in the leadership team of its Validation Interest Group. Gert Moelgaard, who led the group for more than 5 years, will be succeeded by Ralf Gengenbach, Managing Director of gempex GmbH.
The ECA Validation Group is an European wide network. Core topics include process validation and equipment qualification, regulatory requirements, technical challenges, and the support of a harmonized approach. The ECA Good Practice Guide: Integrated Qualification and Validation has just been published in version 2.0.
Ralf Gengenbach has actively supported the establishment of Good Manufacturing Practices for more than 30 years. His commitment is dedicated to the quality of process and product, especially the use of efficiency potentials of an Integrated Qualification.
"The big challenge is bringing together Good Engineering Practice (GEP) and qualification. This is where there is enormous potential for savings and improvements," says Gengenbach. "Focusing on qualification documents alone does not contribute to efficiency and product quality. Rather, qualification should be understood as a necessary activity that uses well-developed test documents to ensure and to provide evidence that technical equipment and systems fulfill their intended purpose and that appropriate tests have been provided as part of GEP."
Gengenbach named the following as further future-looking topics in the context of qualification and validation
- Remote Factory Acceptance Tests (FATs)
- Software based qualification
- Qualification effort according to system categories
- Learning from practical examples (case studies)
- Focus on Industry 4.0 in the pharmaceutical industry
The industry is facing all these issues today, and there is significantly more potential for improvement. The high-profile team of the Validation Group, the shared high level of motivation, and the consensus in commitment mean that the preliminary work done to date can be built on well. Gert Moelgaard will continue to support the group as a member with his high level of expertise and many years of experience.
The entire speech on assumption of office is captured on video and made available at vimeo.
About the ECA Foundation Validation Interest Group
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.
More information: 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.
More information: www.eca-foundation.org.