As we face the new regulatory landscape of 2026, standard 100% visual inspection is no longer sufficient to meet regulatory scrutiny. During a BLA review or Pre-Approval Inspection (PAI), this regulatory scrutiny focuses heavily on whether your process can actually detect what it claims to particularly for Difficult-to-Inspect Products (DIP). USP <1790> explicitly requires that the adequacy of the inspection process be verified, particularly when the container or formulation compromises detection sensitivity.
When dealing with suspensions, amber vials, or cell therapies, your control strategy must prove the inspection process can actually detect intended risks. Gateway Analytical provides the secondary verification required to close this compliance gap:
Sensitivity Verification: Utilizing Secondary Destructive Visible Particulate Screening to quantify detection limits.
Scientific Justification: Providing the data-driven rationale for your AQL performance in non-standard modalities.
Audit-Ready Documentation: Delivering a defensible technical package that proves your inspection process meets USP <1790> expectations.
Ready to fast-track your E&L investigations? Reach out today for a priority consultation with our team:
📞 (724) 443-1900 | ✉️ in**@***************al.com
