How should supplier qualification be addressed in GLP?

• A. Only ensure price is lowest
• B. Qualification of suppliers, material specifications, COAs, and verification of conformity with SOPs
• C. Outsource all decisions to external auditors
• D. Suppliers are not needed in GLP

Answer: (B)

In GLP, making sure all inputs come from qualified suppliers and can be verified against defined standards is essential. This means setting up supplier qualification procedures, defining material specifications, obtaining Certificates of Analysis, and checking that the materials consistently meet the lab’s SOPs and testing requirements. When these elements are in place, you get traceability and reproducibility: you know exactly what was used, its quality level, and that it aligns with how you conduct the study. COAs document identity, composition, purity, and other critical attributes, while material specifications spell out the acceptable properties. Verifying conformity with SOPs ensures that every step—from receiving and storage to handling and testing—follows approved, repeatable processes. Together, these practices safeguard data integrity and regulatory compliance by preventing input-related variability.

Choosing only the lowest price ignores the need for quality and compliance, which can undermine study results. Outsourcing all decisions to external auditors would detach the lab from ongoing responsibility and necessary oversight, reducing control over inputs. Saying that suppliers are not needed contradicts the very reality that GLP studies rely on quality inputs from external sources.