What should GLP data records indicate regarding routine vs nonroutine procedures?

• A. They should indicate whether the operation followed the routine
• B. The weather conditions
• C. The equipment color
• D. The vendor

Answer: (A)

In GLP, records must provide a clear, auditable account of how experiments were performed. The crucial point is to indicate whether each operation followed the established routine or deviated from it. This distinction matters because data generated from routine, validated procedures are generally considered reliable, while deviations can affect the validity and interpretation of the results. By showing whether the procedure adhered to the routine, the record makes it possible to assess data integrity and decide, if needed, whether deviations require justification or additional actions. The other details—weather conditions, the color of equipment, or vendor—do not directly establish whether the procedure was performed as planned, so they’re not the essential information for determining procedural adherence in GLP records.