Glossary
Calibration
Checking, under specified conditions, the relationship between the values indicated by a measuring instrument and a traceable standard value.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Calibration Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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After evaluation of the company's CAPA plan, major deficiencies in the fields of personnel and maintenance/calibration remain unsolved.
EMA · EU GMP NCR (EudraGMDP) · 2019-01-28 -
You could not provide evidence of equipment qualification, maintenance, or calibration of the (b)(4) and (b)(4) used to manufacture your drug products.
FDA · FDA Warning Letter · 2023-10-17 -
Routine calibration, inspection and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
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」, Calibration Korean originalGRM Regulatory Glossary
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