Under FDA GLP, which area is not typically required to have a standard operating procedure?

• A. Client billing for research services
• B. Animal room preparation
• C. Receipt of test articles
• D. Calibration of equipment

Answer: (A)

Under FDA GLP, procedures are required for activities that can influence the quality and integrity of a nonclinical safety study. This includes maintaining a controlled environment in the animal housing through documented room preparation, ensuring proper handling and documentation when receiving test articles to preserve identity, condition, and chain of custody, and having calibrated equipment with recorded maintenance and calibration to guarantee accurate measurements. Administrative tasks like client billing for research services do not affect study conduct, data integrity, or regulatory compliance of the study, so they are not typically required to have GLP-standard operating procedures. In practice, labs may manage billing with separate business procedures, while GLP-focused SOPs concentrate on activities that directly impact the study’s reliability and traceability.