ECA Working Group on Visual Inspection Founded

Recommendation

2/3 March 2021

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The visual inspection of parenterals is an intensively discussed subject - with numerous questions emerging. The Pharmacopoeias provide some information. However, a substantial GMP regulation is missing in both in the European as well as in the American pharmaceutical environment.  herefore 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.

The new Working Group is comprised of industry representatives

• Dr Tobias Posset (Roche Diagnostics)
• Dr Martin Dearden (UCB Pharma)
• Dr Helmut Gaus (Rentschler Biotechnologie)

and supported by

• Klaus Feuerhelm (German GMP Inspector)
• Dr Bernd Renger (Immediate Past Chair of the European QP Association; Bernd Renger Consulting)
• Dr Robert Eicher (Concept-Heidelberg)

The new group's goal is to take advantage of the long lasting experience and knowledge of its members and the learnings from previous 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. 

The new group came together for the first time during the Pharma Congress last March in Düsseldorf/Neuss to discuss the paper's content.   A completion is planned for the ECA Academy Conference "Particles in Parenterals - and beyond" which will be conducted on 24/25th September 2014 in Copenhagen, where this paper is supposed to be distributed to all participants.