Best practice paper on visual inspection to be published in September 2014

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Parenterals

The ECA working group on visual inspection, which was founded this year, is going to publish its first document during the ECA event Particles in Parenterals and beyond. Read more.

http://www.gmp-compliance.org/eca_mitt_4410_8398,Z-PEM_n.html

Press Announcement: Best practice paper on visual inspection to be published in September 2014

The work on this best practice paper has already started earlier this year and has been intensified since the foundation of the working group in March 2014. The goal of this paper is to harmonise the long lasting experience and knowledge from different and approved industrial practices and from presentations from previous conferences.
The paper, which is much rather supposed to be a reference than a strict requirement, will cover Manual and Automated Inspection issues in the following chapters:

  • Workplace (manual)
  • Operation (manual and automated)
  • Qualification
  • Re-Qualification
  • Re-Validation
  • Evaluation of defects
  • Batch release considerations

The paper is still in the group internal discussion phase, but it will be published in its first version during the ECA conference “Particles in Parenterals and beyond” scheduled in Copenhagen, Denmark, from 24-25 September 2014. All participants of the event will receive a copy of this document.

In the future course of this year, the group will decide whether it will be transferred to an interest group which would then allow to further discuss and supplement the content of the paper and to possibly admit further group members.
More information will be published on the group’s webpage, when available.

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