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ECA’s Working Group “Visual Inspections” nominates Chair

11-28-2014 07:33 PM CET | Health & Medicine

Press release from: ECA Foundation

ECA Foundation

ECA Foundation

Although the Pharmacopoeias provide some information relative to visual inspections of parenterals, there is no substantial GMP regulation – neither in the Europe nor in the US. As a result there are ongoing discussions with regard to issues like AQL testing, use of testing kits, qualification/validation/verification of automated systems and training of the manual visual inspection staff. For that reason the ECA Foundation established its “Visual Inspections” Working Group in December 2013. Now the group announced the nomination of Dr Tobias Posset as Chair.

Tobias Posset studied Biochemistry and Chemistry. He has been with Roche Diagnostics in Mannheim, Germany, for 7 years and is currently heading the production support unit in the pharma production. His responsibilities include the in-process control, the particle laboratory, the automated visual inspection machines and the coordination of the manual inspection training.

“We are grateful that Tobias accepted the nomination as Chair of the group.” said Richard M. Bonner, ECA Foundation Advisory Board Chairman. “His experience will help us to develop valuable contents and will thus advance the group.”

About the Visual Inspection Working Group

The “Visual Inspections” Working Group was founded in December 2013. Its goal is to take advantage of the long lasting experience and knowledge of its members and to benefit from learnings from previous courses and conferences to contribute to a harmonisation and to generate a best-practice-paper. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues, though.

After completion of the first version of the best practice paper and presenting it in Copenhagen at the ECA Academy Conference Particles in Parenterals end of September 2014, it is planned to convert the working group into an interest group, open for all ECA members. The interest group members are then invited to provide their feedback to further develop the paper.

About the ECA Foundation

Founded as an independent membership organisation in 1999, the ECA Foundation is Europe’s leading association with regard to pharmaceutical Quality Assurance and GMP compliance. Close to 4.000 members from all over Europe and abroad represent more than 60 countries.

The Foundation’s 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).” For that purpose the organisation developed a range of tools like its website for providing information on an interpretation of regulations, the weekly free of charge GMP Newsletter, the GMP Guideline Manager CD-ROM as well as its internationally acknowledged advanced education course, conference and webinar programme.

The ECA Foundation is comprised of an educational organisation (ECA Academy) and various non-profit interest groups like the European QP Association or, most recently, the Good Distribution Practices (GDP) Group.

For further information on the ECA Foundation please visit www.gmp-compliance.org.

ECA Foundation
Wolfgang Heimes
P.O. Box 10 21 68
69011 Heidelberg, Germany
www.gmp-compliance.org
heimes@gmp-compliance.org

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