News

Validation Group Developments January through April 2026

Find out what the ECA Validation Group was working on and accomplished in the first four months of 2026 - in this report.

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ECA Survey: The use of Artificial Intelligence in Equipment Qualification

One of the hottest topics these days, is the discussion about the use of Artificial Intelligence (AI) in the GMP environment. How far much is the use of AI already used in equipment qualification? This we want to know - with this brief survey.

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Unusual corrective Action for Lack of Process Validation

In a recent Warning Letter, the FDA criticised the lack of process validation. What measures is the FDA requiring in this case and how did the company respond?

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ECA Validation Group comments on Concept Paper regarding the Revision of Annex 15

In February 2026, the EMA published a concept paper announcing a further revision of Annex 15 to the EU GMP Guidelines. This concept paper was open for comments until 9 April 2026. The ECA Validation Group took advantage of this opportunity. What comments were made?

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Statistical Methods from the Perspective of ICH Q9 Quality Risk Management

In a previous news, we discussed the updates to the ICH Q9 training package. Among other things, the slides illustrating how statistical methods can support quality risk management have also been updated. What does this set of slides contain?

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Cleaning and Maintenance in the Focus of the FDA

During an FDA inspection at an active pharmaceutical ingredient manufacturer, the FDA identified shortcomings in the cleaning and maintenance of the equipment. What exactly did the FDA take issue with?

 

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Cleaning Validation Technical Guide - What Does China Expect in Terms of Cleaning Validation?

There are various guidelines on the topic of cleaning validation. A new addition is a technical guide from the Chinese “National Food and Drug Administration Food and Drug Inspection Center.” What does it cover?

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ICH Q9 Training Package updated

Following the revision of the ICH Q9 guideline 'Quality Risk Management 2023', the accompanying training material was also published. This has now been updated with regard to the two annexes. Annex I describes quality risk methods and tools, and Annex II describes possible applications of quality risk management (QRM).

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Risk Assessment as the Basis for Process Validation

In a recent Warning Letter, the FDA criticised the fact that not all parameters of a process were included in a process validation. What are the follow-up measures?

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What does the FDA expect regarding Facility Maintenance?

In a previous news, you could already read about deficiencies in equipment maintenance. However, the FDA also criticised the manufacturer for deficiencies in facility maintenance. What does the FDA expect with regard to 21 CFR 211.58?

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