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Number of samples in PQ/validation of a fully automated 100% visual inspection system

The performance qualification (PQ) or analogously to the validation, a fully automated inspection system in the 100% visual inspection, is carried out by comparing humans and machines. The intention is to show that machine inspections are not worse than human ones. But what number of test samples in PQ/validation of a fully automated (100%) visual inspection is required for a valid comparison?

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USP Chapter <1207>: Container Closure Integrity Testing

The USP Chapter <1207> on the integrity testing of primary containers of sterile dosage forms is currently in the second round of review. Its adoption is expected for this year. Find out more about USP Chapter <1207>.

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Warning letter due to insufficient container-/closure integrity

A site of the company Hospira in Italy received an FDA Warning Letter at the end of March which criticises among others defects concerning the closure of vials and the related possible microbiological contaminations. Read more about the Warning Letter.

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USP Chapter <1790> Visual Inspection of Injections published

The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1) for commenting. Read on.

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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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