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FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.

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FDA presentation at the ECA Conference Particles in Parenterals

At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA's current thinking with regard to the visual inspection of medicinal products for parenteral use.

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New Q&A Document on the Visual Inspection of Parenterals available

The ECA's Visual Inspection Group has developed a new document with answers to frequently asked questions. This new Q&A document is now available for download on the Group's website. Read more about frequently asked questions in the visual inspection.

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Is AQL Testing required within the 100% Visual Inspection?

One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspection of parenterals. The answer is: basically, "yes".

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ECA Visual Inspection Groups works on new FAQ Document

The advisory board of ECA's Interest Group for Visual Inspection is working on a revision of a document with frequently asked questions with regard to visual inspection of parenterals.

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EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.

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Revised USP Chapter <1790> on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

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Exceeding the AQL Limits in the 100% visual Inspection

In addition to trending the results of the 100% visual inspection, inspection of AQL random samples has been established as part of the batch release process. But what happens if the limits in the AQL test are exceeded?

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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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