Glossary
Contract Manufacturer
Also writtencontract manufacturing organizationCMO
A manufacturer performing some or all of the manufacturing operations on behalf of another manufacturer under a written contract.
Source · ICH Q7, §20 Glossary, Contract Manufacturer; 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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After withdrawal of the GMP certificate of the contract manufacturer the QP continued to release the produced batches.
EMA · EU GMP NCR (EudraGMDP) · 2026-08-11 -
Inadequate Design of Facility and Equipment Your firm is a contract manufacturer of sterile injectable drug products produced primarily through aseptic processing including, but not limited to, products for (b)(4) use…
FDA · FDA Warning Letter · 2026-04-21 -
Your firm is a contract manufacturer of over-the-counter (OTC) (b)(4) drug products.
FDA · FDA Warning Letter · 2026-02-03
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, Contract Manufacturer; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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