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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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Which Test Sets are used in the 100% Visual Inspection?

In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.

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USP: Further Updates on "Residual Solvents" published for Comments

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

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