A study drug will be shipped, stored, and mixed at the hospital pharmacy and will...

The Standard Operating Procedure (SOP) outlines the process for shipping, storing, mixing, and transferring the investigational product (IP) between locations. SOPs ensure that all steps are consistently followed and documented, maintaining the integrity and quality of the IP throughout the handling process. This is critical for maintaining compliance with Good Clinical Practice (GCP) and ensuring patient safety.

GCP guidelines specify that SOPs should cover the handling, transfer, and storage of investigational products to ensure quality control.

"SOPs provide detailed guidance on the handling and transfer of investigational products to ensure consistency and compliance."

Objectives:

Maintain the integrity of IP during transport and handling.

Ensure compliance through standardized procedures.