In outsourcing, who is responsible for the quality of the medicinal products produced?

In principle, a marketing authorisation holder (MAH) may delegate all obligations under pharmaceutical law to third parties. However, the commissioning of third parties with certain activities does not release the MAH from his final responsibility for these activities: He remains responsible for the quality of the manufactured medicinal products even if he has them manufactured or tested in whole or in part under contract.

[GMP Compliance Adviser, Chapter 1.L]



You can find out more about this topic:

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business!