11.1 Investigational products used in a clinical trial should be manufactured in accordance with applicable GMP standards.
11.2 Measures should be in place to ensure that the investigational product provided to trial participants retains its quality.
11.3 Investigational products should be used in accordance with the protocol and relevant trial documents.
11.4 Manufacturing, handling and labelling of investigational products should be undertaken in a manner that aligns with treatment assignment and maintains blinding, where applicable.
11.5 Investigational product labelling should follow applicable regulatory requirements.
11.6 Appropriate processes should be implemented for the handling, shipping, storage, dispensing, returning and destroying or alternatively disposing of the investigational product.