Glossary
Robustness
The degree to which an analytical procedure is unaffected by small deliberate variations in the test conditions.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Robustness Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The use of deficient media similarly compromises the validity of microbiological test results and raises questions about the suitability and robustness of your methods.
FDA · FDA Warning Letter · 2026-10-13 -
(b)(4) methods should be rigorously studied, and qualified, to assess their capability and robustness under various conditions, machine settings, container-closure sizes, defect types, product characteristic, and other variables.
FDA · FDA Warning Letter · 2026-08-18
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」, Robustness Korean originalGRM Regulatory Glossary
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