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VIRTUAL QC LAB • SCENARIO 01
OOS Investigation: The Result That Does Not Fit
You are the QC analyst assigned to HPLC Station 03. A finished-product assay has generated an out-of-specification result. Your task is to preserve the data, investigate scientifically, document what you find and decide what must happen next.
ProductPQS Training Tablet 100 mg
BatchIR-260904-B17
TestAssay by HPLC
Result87.6% (Spec 95.0–105.0%)
Training rule: This is an illustrative pharmaceutical quality scenario. Numerical values and workflow elements are fictional and do not replace your approved OOS SOP, validated method, specification, Quality Unit decision or applicable regulatory requirements.
Designed around the investigation principles described in FDA's final guidance on investigating OOS test results for pharmaceutical production.
SIMULATION COMPLETE
OOS Investigation Assessment
Your score reflects decision quality, evidence review, documentation behavior and investigation scope.