Glossary
Biological Indicator
A test piece carrying microorganisms of known resistance to a sterilisation process, used to confirm the effectiveness of a sterilisation cycle.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Biological Indicator; EU GMP Annex 1 Korean original
Related sections
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Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Biological indicators are not used to verify the adequacy of the sterilization cycle of <Redacted B4> to sterilize your firm's glassware used in sterile operations.
FDA · FDA 483 · 2024-01-17 -
Biological indicators are not used properly to verify the adequacy ofthe sterilization cycle.
FDA · FDA 483 · 2024-01-17 -
You did not appear to use biological indicators <Redacted B4> during <Redacted B4> and <Redacted B4> of finished drug products.
FDA · FDA 483 · 2021-09-17
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」, Biological Indicator; EU GMP Annex 1 Korean originalGRM Regulatory Glossary
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