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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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ECA comments on FDA Guideline on Visual Inspection

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

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ECA publishes Contamination Control Strategy Guideline

In order to support its members, but also to support the industry in general in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA has published a CCS Guideline. This document provides guidance and a template for the development of a contamination control strategy.

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FDA publishes Draft Guidance on Visual Inspection of Parenterals

It has been known for some time that the US FDA is working on its own guide on the visual inspection of parenterals. Now the draft has been published as a 15-page document.

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Particles lead to Warning Letter for Japanese Sterile Manufacturer

The frequent occurrence of particles in sterile injection solutions and the inadequate investigation of the cause led to a Warning Letter to a sterile manufacturer in Japan. In addition, data integrity breaks and falsifications had occurred in the environmental monitoring.

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