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Contract development and manufacturing organisation (revision 1)

Old revision·09:00, 8 Nov 2024·MoveRequestMio

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Contract development and manufacturing organisation
AbbreviationCDMO
FunctionDevelopment and manufacture to a customer specification
ConsequenceBrand and manufacturer are frequently different
Topic infobox · conventions

A contract development and manufacturing organisation (CDMO) develops processes and manufactures material to the specification of a customer who sells it under their own name. The arrangement is ordinary across the pharmaceutical and fine-chemical industries and is not in itself remarkable.[1]

Its consequence for anyone reading supplier documentation is that the organisation named on a catalogue is not necessarily the organisation that made the material. A brand may be a manufacturer, a distributor of its own contract-manufactured material, or a reseller of another's — and the documentation may not distinguish these.[2]

References

  1. ^ International Council for Harmonisation, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (2000).
  2. ^ ISO 9001:2015, Quality management systems — Requirements.