ICH E6(R3) - Good Clinical Practice P11: Manufacture investigational products under applicable GMP, preserve their quality, use them per protocol, keep handling and labelling consistent with treatment assignment and blinding, label them as regulations require and control their full handling cycle

What does P11 require?

Investigational products should be made under applicable GMP, kept at the quality they were supplied in, used as the protocol and trial documents say, manufactured, handled and labelled so as to match treatment assignment and keep the blind, labelled according to regulations, and handled, shipped, stored, dispensed, returned and destroyed or otherwise disposed of under appropriate processes.