What is the purpose of a change control process in GLP?

• A. To track laboratory personnel performance
• B. To enforce strict secrecy of study data
• C. To manage changes to procedures, equipment, or materials with approvals, documentation, and impact assessment
• D. To accelerate audits by skipping documentation

Answer: (C)

In GLP, change control ensures that any modification to procedures, equipment, or materials that could affect study outcomes is handled through a formal process. A proposed change is documented, reviewed, and approved before it is implemented, and an impact assessment determines whether qualification, validation, or training needs to be updated. This creates an auditable trail and protects data integrity, quality, and regulatory compliance. For example, changing a pipette calibration interval or updating a SOP requires documenting the change, evaluating its effect on results, and obtaining authorization. Tracking personnel performance or secrecy of data aren’t the goals, and skipping documentation would undermine GLP.