Risk-Assess a Cleaning Change
Apply a converging ICH Q9 risk walk to a proposed cleaning-process change.
The trigger A cleaning cycle change promises faster turnaround on shared equipment. The same change can reduce human error or create hidden residue risk depending on evidence. ICH Q9 walk Hazard -> Impact -> Control -> Review Do not score the change until the pathway is visible. Risk decisions must be based on product/process knowledge and reviewed as knowledge changes. Step 1 Define The Hazard The proposed spray cycle replaces manual rinsing. What is the first risk question? Step 2 Select Evidence The team now knows the affected shared equipment and worst-case product family. What evidence should drive the decision?…
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