Certified Pharmaceutical GMP Professional Practice 2025 – Your All-in-One Guide to Exam Success!

The distinction between a protocol and a report is essential in Good Manufacturing Practice (GMP) frameworks. A protocol serves as a comprehensive document that outlines the specific methodology for conducting tests or studies. It details the objectives, procedures, and expected outcomes, ensuring that all aspects of the study are clearly defined before starting. This structured approach is crucial for maintaining consistency and compliance with regulatory standards during the testing or study phases.

On the other hand, a report is created after the conclusion of a study or testing procedure. It encapsulates and summarizes the findings, providing an analysis and discussion of the results obtained from the protocol. Reports communicate outcomes to stakeholders and document whether the objectives outlined in the protocol were met, as well as any deviations or unexpected observations during the process.

The clarity in this relationship—that the protocol describes how to conduct the testing and the report explains what the testing revealed—highlights why the first option accurately defines the difference between the two. The other options mischaracterize the functions of protocols and reports, particularly in relation to marketing, specific uses, and internal document classifications.