News

Revised Container-/Closure-Integrity Testing (CCIT) Position Paper available

The ECA Visual Inspection Group has completed the revision of the CCIT position paper. The new document, version 3.0, is now available in the Download/Members section of the group's website. New features in the revised version include supplementary interpretations of Annex I CCI(T) requirements, inclusion of prefilled syringes, addition of the CCI verification within stability testing. Find out more.

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ECA revises Container-/Closure-Integrity Testing (CCIT) Position Paper

The ECA Visual Inspection Group is currently working on a revision of its Container-/Closure- Integrity Testing (CCIT) Position Paper. The current version from 2022 is to be replaced by version 3.0 in November of this year. New features in the revised version include Supplementary interpretations of Annex I CCI(T) requirements, inclusion of prefilled syringes, addition of the CCI Verification within stability testing.

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New Version 5.0 of the ECA Visual Inspection Guide for Parenterals

The ECA Visual Inspection Group has finalized the new Version 5.0 of its guide. The revision includes extensive editorial and content updates, as well as a new chapter on the inspection of difficult-to-inspect units and detailed guidance on the procedure to follow when particles are detected during the AQL test.

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Visual Inspection Group Developments [May through August 2025]

Find out what the Visual Inspection Group was working on and accomplished in the first four months of 2025 - in the latest report.

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Neue Version 5.0 des ECA Visual Inspection Guide for Parenterals

Die ECA Visual Inspection Group hat die neue Version 5.0 finalisiert. Enthalten sind umfangreiche redaktionelle und inhaltliche Veränderungen, sowie ein neues Kapitel über die Inspektion von 'difficult-to-inspect" Einheiten und ausführliche Hinweise zum Vorgehen bei Partikelfund im AQL Test. Vorgestellt aus ausgegeben wird das neue Dokument auf der jährlichen Konferenz der ECA Visual Inspection Group, 22.-23. Oktober in Wien. Lesen Sie weiter.

 

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Visual Inspection Group Developments January through April 2025

Find out what the Visual Inspection Group was working on and accomplished in the first four months of 2025 - in the latest report.

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Requalification of an Automatic Inspection System (AVI)

If the visual inspection is carried out with an automatic inspection system (AVI), function tests should be carried out regularly. Does the AVI system still need to be requalified regularly?

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Automated Visual Inspection: GMP Relevance of false Reject Rates

During the validation and operation of fully automated inspection machines, there are always problems with high false reject rates, i.e. the incorrect rejection of good objects. Are there GMP requirements in this regard?

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New version 4.0 of the ECA Visual Inspection Guide published

The ECA Visual Inspection Group has published the new version 4.0 of its guide on the group's website. In addition to some clarifications, version 4.0 also contains a completely new chapter.

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What are the FDA Requirements for Equipment Qualifications?

What are the FDA requirements for equipment qualifications? This is a question that requires a more detailed look into the regulations. However, a current Warning Letter offers a more simple way for information.

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