Which activity is not required to have a standard operating procedure per the FDA Good Laboratory Practice regulations?

• A. Animal room preparation
• B. Receipt of test articles
• C. Client billing for research services
• D. All of the above?

Answer: (C)

Under GLP, standard operating procedures are required for activities that directly affect the conduct, quality, and integrity of nonclinical study data. Procedures for preparing the animal room and for receiving test articles are tied to the study’s environment, dosing, handling, and chain of custody; having SOPs here ensures consistent performance, proper documentation, and traceability.

Billing for research services, on the other hand, is a business and administrative function. While a facility may have internal procedures for finances, GLP regulations do not require an SOP for billing because this activity does not influence the conduct of the study or the integrity of the data.