Glossary
Depyrogenation
A process that removes or inactivates pyrogens on product contact surfaces or materials to a defined level.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Depyrogenation; EU GMP Annex 1 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to validate your (b)(4) to ensure it can maintain adequate temperatures to achieve required depyrogenation.
FDA · FDA Warning Letter · 2021-04-27 -
Your firm uses a <Redacted B4> for the depyrogenation of glassware in the production of sterile, injectable drug products.
FDA · FDA 483 · 2024-01-17 -
Your firm uses a <Redacted B4> for the depyrogenation of glassware used in the production of sterile, injectable drug products.
FDA · FDA 483 · 2024-01-17
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」, Depyrogenation; EU GMP Annex 1 Korean originalGRM Regulatory Glossary
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