News

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?

In the previous newsletter, you could read about a concept paper from the EMA describing the planned changes to Annex 15 (Qualification and Validation) of the EU GMP Guidelines. Find out more in detail what the concept paper on the Annex 15 revision contains.

In a recent Warning Letter, the FDA addressed deficiencies in a water system. Two references from the US GMP rules are cited. On the one hand, 21 CFR 211.63 with reference to equipment and, on the other hand, 21 CFR 211.100 with reference to process controls ('validation'). What bothered the FDA?

Phase 3 (ongoing/continued process verification) is the longest phase in the validation life cycle. Many companies use statistical process control (SPC) for this purpose. Concept Heidelberg conducted a survey for the ECA specifically on this topic. Among other things, the ECA wanted to know which control charts are used and what the limits are for cpk-values, etc. Read part II of the survey results summary.