The Drug Product Validation checklist streamlines the validation process and ensures adherence to regulatory standards and helps to reduce deficiencies and further development of data during review cycle.

      By utilizing a validation checklist, applicants can systematically validate the method according to USFDA requirement and ICH Q2 guidance. This proactive approach enhances the overall quality of the submission and minimizes the likelihood of deficiencies being identified during the FDA's review and ensure all regulatory requirements have been met. Validation checklist reduces the risk of data inconsistencies and mitigates the need for further data development or additional testing, which can delay the approval process.

     The Drug Product Validation Checklist is aligned with FDA guidelines, reflecting the importance of a methodical and evidence-based approach to validating that all essential quality attributes are maintained. The checklist also serves as an essential tool during internal audits and inspections, ensuring that all validation activities are in line with FDA expectations and are documented comprehensively.

     Ultimately, a validation checklist serves not only a regulatory requirement but as a strategic tool to measure to safeguard the quality and integrity of the drug product, facilitating a smoother and more efficient review cycle.