ECA Visual Inspection Group - Update

The ECA Visual Inspection Group has been founded in 2013 by representatives of the pharmaceutical industry and GMP authorities with the following objectives:

  • Assemble knowledge on visual inspection of parenterals
  • Develop white papers and guidances on visual inspection and related topics
  • Share the knowledge amongst the group members
  • Establish an annual group event on visual inspection

The members of the board of the Visual Inspection Group have developed a guidance document on best practices in the visual inspection of parenterals. The guidance has been shared with GMP authorities, e.g. with the PIC/S. It is available for all group members in the actual version 3.0.

A position paper on the container-/closure-integrity testing has also been developed and is available as version 1.1 on the group's webpage.

Already six events on the testing of parenterals with focus on particulate matter have taken place in Copenhagen, in Vienna, in Berlin, in Barcelona and in Hamburg.

The group's chairman Dr Tobias Posset has become official member of EDQM's Expert Group 12. The revised chapter Ph. Eur. 2.9.20 on visual inspection has been published in 2018 and the feedback from ECA has been included within the new Pharmacopeia wording.

An updated version of the guidance document with editorial changes and clarifications will be published in the 1st quarter of 2019.
The members of the board of the visual inspection group are waiting for the finalisation of the Annex 1. It will then be decided whether the revised Annex 1 has an impact on the ECA Visual Inspection Guidance document and whether it has to be further updated or not.

The annual meeting of the group will take place in Vienna this year, from 8th to 10th of October 2019. The programme is currently being developed. The topcis of Container-/Closure-Integrity Testing and Visual Inspection will be addressed.

Find out more about visual inspection and become a member for free at the webpage of the ECA Visual Inspection Group.

Source:
Dr Tobias Posset
Chairman of the ECA Visual Inspection Group

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