Industry Practices · Pharmaceutical Industry Practical Discussion
What is the difference between CMO, CDMO, CRO and contract laboratory services?
Four outsourcing models, what each one does, and when to use which.
- Concept
- Practical example
- Process
- Documentation
- Technology
- Quality considerations
- Example use case
01Concept
A CMO manufactures an already-developed product. A CDMO develops and manufactures. A CRO runs research studies. A contract laboratory performs testing. Many projects use more than one.
02Practical example
A new generic may use a CDMO for development and exhibit batches, a CRO for a bioequivalence study, and a contract laboratory for stability testing.
03Process
- 1
Identify what is missing: development, manufacturing, studies or testing
- 2
Match to provider type
- 3
Define interfaces between providers
- 4
Agree quality responsibilities
04Documentation
- Quality agreements per provider
- Responsibility matrix
- Project plan
05Technology
Shared project dashboards help when several providers deliver parts of one programme.
06Quality considerations
Each provider needs qualification appropriate to the GxP area it works in.
07Example use case
A programme manager maps each work package to CMO, CDMO, CRO or laboratory before contracting.
Example use cases are illustrative. This article is general educational information, not regulatory or legal advice.
