Glossary
Worst Case
Test conditions set at the upper and lower limits and circumstances that give the greatest chance of process failure.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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media fills were not performed that closely simulate aseptic production operations incorporating as appropriate worst case activities and conditions that provide a challenge to aseptic operations .
FDA · FDA 483 · 2024-01-17 -
Failure to conduct media fills that closely simulates aseptic production operations under the worst case, most challenging and stressful conditions.
FDA · FDA 483 · 2021-10-20 -
Failure to conduct media fills that closely simulates aseptic compounding operations under the worst case, most challenging and stressful conditions.
FDA · FDA 483 · 2022-09-27
