News

Update of Training Material for ICH Q8, Q9 and Q10

In a detailed news article in late 2023, we referred to the new training package for the revision of the ICH Q9 guideline (quality risk management). The ICH has now published updated training material on the implementation of ICH Q8, Q9 and Q10.

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The ICH Q9 Briefing Package - a Forgotten Document?

Due to the revision of the ICH Q9 document on quality risk management, the ICH has also published comprehensive training material on the “main text”. However, even the revised version of the ICH Q9 (R1) document still has two annexes. Training slides that the ICH published as a “Briefing Package” in 2006 are still available on the ICH website, though. Is the "Briefing Package" still up to date?

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New FDA Guidelines: Batch Uniformity and Drug Product Integrity / Advanced Manufacturing Technologies

The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation Program."

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Qualification Deficiencies from the FDA's Perspective

There is relatively little information on the FDA's requirements for equipment qualification. A current Warning letter provides guidance.

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Risk Analysis in Case of Insufficient Process Validation

Risk analyses are an essential prerequisite prior to process validation. But how should inadequately validated processes be handled in retrospect? The FDA comments on this in a recent Warning Letter.

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The first GMP-Song ever?

Perhaps the first GMP song? A somewhat unusual subject. Listen to an AI generated song about equipment qualification.

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ECA Validation Group launches redesigned Website

The ECA Validation Group website has been extensively revised. Find out what has changed and what you will find on the new ECA Foundation Group website. Enjoy browsing the new look.

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FDA criticises the Use of pharmaceutical Facilities for industrial Products

Recently, several Warning Letters have been published by the US FDA criticising the use of non-dedicated equipment for pharmaceutical and non-pharmaceutical products. In a recent Warning Letter, this is once again made very clear.

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Results of ECA Survey about Artificial Intelligence in Equipment Qualification

How is Artificial IntelligenceI used in equipment qualificattion? This is a question the ECA wanted to clarify with a survey. The survey contained 8 questions. Altogether 60 participants completed the survey. In the following, you will find a summary of the questions asked and their answers.

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FDA criticises Equipment Qualification and Process Validation

In a current Warning Letter, the FDA has criticised inadequate device qualification and deficiencies in process and cleaning validation. What does the FDA require?

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