For complex injectable formulations, meeting USP <787>, <788>, and <789> requirements does not automatically translate into regulatory confidence.
When Method 1 and Method 2 suitability is assumed rather than explicitly verified, subvisible particle data becomes vulnerable during audits, filings, and post-approval changes.
Proteinaceous drugs, suspensions, and advanced therapies frequently challenge standard subvisible particle methods. Formulation interference, aggregation behavior, and optical limitations can compromise data quality if method suitability is not demonstrated for the specific product matrix. In these cases, technically compliant results may still fail to withstand regulatory scrutiny.
Our Method Verification Gap Check evaluates whether your current subvisible particle testing strategy is scientifically appropriate, properly verified, and defensible for its intended use. This review focuses on identifying gaps in Method 1 and Method 2 verification, documentation, and justification before they become audit findings or filing questions.
By proactively addressing these gaps, teams can strengthen governance, reduce investigation risk, and support a predictable path to regulatory submission.
Validate before audit or filing exposure occurs.
Schedule a Method Verification Gap Check with Gateway Analytical to assess the defensibility of your subvisible particle methods and ensure your data package is inspection-ready.
📞 (724) 443-1900 | ✉️ in**@***************al.com
