Glossary
Manufacturer
A person or company holding an authorisation to manufacture medicines under the applicable regulation.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Manufacturer Korean original
Related sections
WHO TRS 986 Annex 2, Part 1 의약품 제조 및 품질관리에 관한 규정 [별표 1]
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Action taken/proposed by the NCA: Others The manufacturer did not previously have EU GMP certification.
EMA · EU GMP NCR (EudraGMDP) · 2024-03-07 -
Others Member states should consider not initiating or authorising new marketing authorisations with this site listed as a finished product manufacturer until the recommended non-compliance statement to be issued remains in place or is not superseded with a GMP certificate.
EMA · EU GMP NCR (EudraGMDP) · 2026-08-24 -
In response to Observation 1 of the Form FDA 483, you state that your investigation was extended to other batches and bulk drug samples were submitted to the manufacturer.
FDA · FDA Warning Letter · 2022-06-14
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」, Manufacturer Korean originalGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
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