Packaging and labeling investigational products/study drugs

Investigational product/study drug (IP) should be packaged to prevent contamination and unacceptable deterioration during transport and storage, its labelling should comply with applicable regulatory requirements, and labelling should be in a manner that protects the blinding, if applicable. This procedure describes the generation of labels for, and packaging of, IP by the trial site that is in accordance with a typical Good Pharmacy Practice guideline.