According to the AQbD principles defined in ICH Q2(R2), ICH Q14 and USP<1220> the number of sample prep and injections replicates should already be defined during the development stage of an analytical procedure. USP <1210>…
Best Practices in Peak Tracking One of the critical bootle necks for any chromatographic modelling is accurate peak tracking. Incorrect peak name assignments will consequentially lead to poor or even wrong predictions. Therefore, adequate care…
Manual Peak Integration under GMP – Just a Single Aspect During training courses, especially when customers have used other CDS systems than Empower before, I’m regulary confronted with the statement that manual peak integration, as…
In previous blogs we have provided explanation about robustness simulation in Fusion QbD and setting suitable distances between the single study factor levels. As explained in these notes, for both topics we need to know…
When starting to adopt DOE in AQbD I noticed that even experienced chromatographers (or should I say especially this group?) often try to take over established routines when setting up their first experiments in Fusion…
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