Quality lifecycle planning for process performance qualification (PPQ) remains a critical bottleneck for cell and gene therapy developers. Guidance and case studies highlight common failure modes—insufficient characterization of critical quality attributes, inadequate scale‑down models and regulatory misalignment—that delay commercialization. Authors recommend early PPQ engagement, robust analytics and cross‑functional regulatory strategies to reduce noncompliance risk and streamline the bench‑to‑bedside transition for advanced therapies.