The visual inspection of parenterals is an intensively discussed subject – with numerous questions emerging. A substantial GMP regulation is missing in both
in the European as well as in the American pharmaceutical environment. Therefore there are continually discussions internally and during inspections 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 "Visual Inspections" Working Group was founded in December 2013 by the
Mission of the group is to assemble knowledge on visual inspection of parenterals for example by continuously developing the best practice paper on visual inspection.
So the group took advantage of the long lasting experience and knowledge of its members and the learnings from previous courses and conferences to contribute to a
harmonisation and to generate a best-practice-paper on visual inspection. Much rather than a strict requirement document, this paper is intended to be a reference
for controversial issues. A regular update of the paper is intended to keep it up to date. The first version of this paper has been published in September 2014 and has
been distributed to all participants of the ECA conference "Particles in Parenterals", 24-25 September 2015 in Copenhagen. Mission of the group is to assemble knowledge
on visual inspection of parenterals for example by continuously developing the best practice paper on visual inspection.
Board of Directors:
|Felix Krumbein (InspectifAI (Körber)) Chairman
||Dr Tobias Posset (Roche Diagnostics)
|Dr Martin Dearden (formerly PaxVax Berna)
|Dr Helmut Gaus (WinSol; formerly Boehringer Ingelheim)
|Dr Martin Becker (Siegfried Hameln)
|Al Goodwin (Amgen SA)
|Dr Robert Eicher (Concept Heidelberg)
|Dr Bernd Renger (Immediate Past Chair of the European QP Association; Bernd Renger Consulting)
Authority Advisory Board
The Authority Advisory Board is not part of the legal structure. The Advisory Board Members support the Visual Inspection Group on a case by case decision and not for all of its activities. The following Board Members of the ECA Foundation Board support the
Visual Inspection Group:
||Klaus Feuerhelm (GMP Inspector, Germany)
Please find here all
Members of the Authority Board of the ECA Foundation.