What action would improve GLP compliance when pathology data is required by the protocol but was not sent with necropsy specimens?

• A. Modify the SOP to require sending necropsy records with specimens
• B. Continue practice without necropsy data
• C. Remove pathology requirements from the protocol
• D. Delay pathology data until after the study ends

Answer: (A)

When GLP compliance hinges on data being available with the samples, the fix is to build that requirement into routine practice. Updating the standard operating procedure to require sending necropsy records with the specimens makes the process repeatable, assigns responsibility, and creates an auditable, traceable link between the pathology data and the samples. It ensures the protocol’s data requirements are actually met at the time of specimen handling, improving data integrity and regulatory readiness. Continuing the current practice would leave required data missing and violate the protocol. Removing pathology requirements would weaken the study’s design and regulatory footing. Delaying pathology data until after the study ends would compromise data integrity and the ability to review records in a timely, compliant manner.