What must a facility create and follow as required by the Good Laboratory Practice (GLP) Regulations?

What must a facility create and follow as required by the Good Laboratory Practice (GLP) Regulations?

• A. Standard Operating Procedures
• B. Occupational health and safety program
• C. Disaster plan
• D. Facility budget

Answer: (A)

GLP emphasizes consistent, verifiable data through standardized methods. A facility must create and follow written Standard Operating Procedures that specify exactly how each procedure is performed, by whom, and how records are handled. SOPs provide a controlled, repeatable framework for all activities involved in a study—from animal care and dosing to sample collection, data recording, and quality assurance checks. This standardization makes results reproducible, supports training so staff perform tasks the same way, and allows audits to verify that methods were applied consistently. While an occupational health and safety program, a disaster plan, and a facility budget are important for overall operation and safety, they are not the GLP-specific requirement that guarantees data integrity through standardized procedures.

GLP emphasizes consistent, verifiable data through standardized methods. A facility must create and follow written Standard Operating Procedures that specify exactly how each procedure is performed, by whom, and how records are handled. SOPs provide a controlled, repeatable framework for all activities involved in a study—from animal care and dosing to sample collection, data recording, and quality assurance checks. This standardization makes results reproducible, supports training so staff perform tasks the same way, and allows audits to verify that methods were applied consistently.

While an occupational health and safety program, a disaster plan, and a facility budget are important for overall operation and safety, they are not the GLP-specific requirement that guarantees data integrity through standardized procedures.