Is a contract fabricator or packager responsible for qualification of utilities and systems and cleaning validation or is it the responsibility of the distributor? And what about the validation of the manufacturing/packaging process and test methods?

The contract fabricator is responsible for the qualification of utilities and systems and cleaning
validation as those requirements are not product specific.
For process validation and test method validation, the main responsibility rests with the distributor, according
to Section C.02.003 of the Food and Drug Regulations. The contract fabricator, packager or tester retains
responsibility in terms of process or test methods validation unless a written agreement is signed by both
parties that excludes the responsibility of the contract fabricator, packager or tester to perform validation
activities.