The Clinical-to-Commercial Quality Gap: Closing the Maturity Debt Before Pre-Approval Inspection

Transitioning from clinical development to commercial manufacturing requires more than scaling production. Pharmaceutical, biologics, and cell and gene therapy manufacturers must ensure their quality systems mature alongside their products to meet FDA expectations. Gaps in process validation, change control, data integrity, and quality oversight can create significant risks during pre-approval inspections. This white paper examines the challenges of clinical-to-commercial manufacturing and outlines a phase-based approach to strengthening pharmaceutical quality systems, addressing compliance gaps, and preparing for successful commercialization.

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