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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
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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…
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