News

Best Practice Paper on Visual Inspection now available for download

After the transition of the ECA Visual Inspection group from a working to an interest group, it is now possible to join the group for free. Group members have access to the full site content including the download of the best practice paper on visual inspection. Read more.

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ECA's Working Group "Visual Inspections" nominates Chair

The ECA Foundation established its "Visual Inspections" Working Group in December 2013. Now the group announced the nomination of Dr Tobias Posset as Chair. Learn more.

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Warning Letter: Deficiencies in Visual Inspection

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals justified by deficiencies in the visual inspection of vials. Read more here.

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New Q&A concerning Visual Inspection

The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL inspections. To find some of these questions and answers by Dr. Tobias Posset (Head of Production Support at Roche Diagnostics) please read here.

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Commentary Regarding new USP Chapters <787> and <1787> for Particulate Matter Guidance

There are new chapters in the USP regarding testing of subvisible particles. Chapter Subvisible Particulate Matter in Therapeutic Protein Injections <787>  became official August 1, 2014. The informational chapter <1787> was developed to support chapter <787> and will be published in USP 38 in November and become official on May 1, 2015. Read more.

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Questions and Answers on the Topic "Visual Inspection"

On the topic of visual inspection of parenterals there are always questions on how to implement in practice. Some compiled Q&As are supposed to support you in this implementation. Find out more.

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Particles Filtration Not Acceptable

The EMA has recently added an interesting question to its Questions & Answers section. How acceptable is filtration of particles prior to the administration of a medicinal product for parenteral use? Read more.

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ECA Working Group on Visual Inspection Founded

The European Compliance Academy now counts a new working group. In addition to the already existing working groups on validation, GDP, QC, rapid microbiology methods and the QP Association, a new group was created at the beginning of the year to address GMP Compliance in the visual inspection of parenterals. Read more here.

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News from the US on particles in injectables

Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. There are some upcoming changes in the USP with respect to particle inspection, which you can find here.

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USP visual inspection expert answers question regarding AQL testing

Questions about the implementation or the need for AQL testing in the visual inspection of parenteral drugs are becoming more frequent. To get concrete answers to a specific question read on.

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