Who is required to validate a drug's stability data as part of a marketing application?

The requirement to validate a drug's stability data as part of a marketing application falls to a qualified person. This individual typically has expertise and training in regulatory compliance, quality assurance, and stability study protocols. Their role is crucial, as this validation ensures that the data presented supports the drug's safety and efficacy throughout its shelf life. This process includes confirming that the stability data is obtained through appropriately designed and conducted stability studies, aligning with regulatory guidance and standards.

A regulatory consultant may assist in preparing documentation and advising on best practices, but they do not have the same authoritative responsibility as a qualified person. Similarly, while the marketing team and sales department participate in the drug's marketing and promotion, they typically do not engage in the technical validation of stability studies. Thus, a qualified person is integral in the validation process, ensuring that the application meets regulatory requirements and standards for quality data.