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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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Revision of EU-GMP Annex 15: Increased Focus on Deviation Management

Annex 15 is about to become far more relevant for API manufacturers. Stronger requirements for deviation investigations and process understanding will raise the bar for quality oversight across the supply chain.

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Rationale for Limit Selection in Process Validation

In a recent warning letter, the US FDA criticised deficiencies in the process validation of a tablet manufacturing process. In particular, the scientific justification for the selected process parameter limits was questioned.

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The GMP Relevance of Equipment Maintenance from FDA's Perspective

In our News item "Dedicated Equipment Should also be Included in Cleaning Validation" dated 18.02.2026, we reported on deficiencies in cleaning validation that were criticised by the US FDA. However, this section of the FDA regulations addresses not only cleaning, but also equipment maintenance - an area in which the FDA identified significant deficiencies during its inspection. So, what specific deficiencies were highlighted by the FDA?

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Dedicated Equipment Should also be Included in Cleaning Validation

In a recent Warning Letter, the U.S. FDA criticised inadequate cleaning of non-dedicated equipment. However, cleaning of dedicated equipment was also criticised. What did the FDA find?

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