Investigational products should be manufactured, handled, and stored in accordance with which standard?

• A. Good Laboratory Practice
• B. ISO 9001
• C. Good Clinical Practice
• D. Good Manufacturing Practice

Answer: (D)

Good Manufacturing Practice governs the production, handling, and storage of investigational products. It outlines the quality systems, facilities, equipment, process validation, documentation, labeling, storage conditions, and traceability needed to ensure the product’s quality and safety throughout its lifecycle. Good Laboratory Practice covers nonclinical studies and data quality, not manufacturing; Good Clinical Practice focuses on protecting trial subjects and data integrity in the clinical trial itself; ISO 9001 is a general quality management standard not specific to pharmaceutical manufacturing. Therefore, GMP is the standard that applies to investigational product manufacturing, handling, and storage.