Glossary
Worst Case
Test conditions set at the upper and lower limits and circumstances that give the greatest chance of process failure.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Worst Case; EU GMP Annex 15 Korean original
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Worst Case; EU GMP Annex 15 Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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