Glossary
Bioburden
The number and type of microorganisms present on a material, product, person, surface, or in the environment.
Source · EU GMP Annex 1 (2022), Glossary, Bioburden; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, you relied on the (b)(4) sterilization process without monitoring pre-sterilization bioburden.
FDA · FDA Warning Letter · 2025-03-18 -
Your approach to calculating the SAL for lots of finished unsterilized units of your products with TNTC pre-sterilization bioburden results is not…
FDA · FDA Warning Letter · 2023-09-29 -
Your firm lacked meaningful investigations of failed sterility and bioburden test results.
FDA · FDA Warning Letter · 2025-08-05
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 1 (2022), Glossary, Bioburden; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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