The Either-Or Trap: Consequences of Enhanced Mechanical Calibration vs Fully Qualifying your Dissolution Equipment

Dissolution and drug release testing are used to demonstrate the consistency of pharmaceutical product performance within and across batches of critical medicines. Learn from a USP expert the importance of fully qualifying dissolution testing equipment. Understand the rationale for developing a new formulation used for the performance verification test (PVT) mentioned in USP General Chapter <711> Dissolution. See USP data that demonstrates the improved sensitivity of USP’s PVT reference standard—the dissolution performance verification standard (DPVS). Understand the risks of choosing an either-or approach when it comes to considering mechanical calibration and performance verification testing (PVT) for dissolution instrument qualification procedures.

By attending this presentation, you will learn about:

• The rigorous development of the USP Dissolution Performance Verification Standard (DPVS)
• Potential sources of variability in dissolution testing related to the equipment operation and setup
• Risks associated with only choosing mechanical calibration or performance verification testing in the qualification of dissolution testing equipment
• What it means to have a “fully qualified” dissolution instrument according to USP specifications.

Who should attend:

• Pharmaceutical industry QC analysts, lab supervisors, formulation scientists, regulatory professionals, and all those responsible for dissolution method execution, development, and compliance.

Presenter: Mark Liddell, PhD (Senior Manager, Dosage Form Performance Laboratory, USP) 

Dr. Mark Liddell is the Senior Manager of Dosage Form Performance Laboratory (DFPL) at USP’s Rockville headquarters. Mark has worked at USP for 18 years, pursuing and promoting a deeper understanding of the fundamentals of dissolution science. At USP Mark’s work has focused on improving the reliability and reproducibility of compendial dissolution and drug release test methods. DFPL is responsible for overseeing the development, manufacture, and monitoring of performance verification test (PVT) reference materials used to demonstrate the suitability of dissolution testing apparatuses. Mark also supports USP education course offerings, reference standard technical services, the USP Dosage Form expert committee, the USP Performance Verification Testing expert panel, and various other internal and external stakeholders as a dissolution/drug release testing subject matter expert.  Mark’s journey spans over 25 years, dedicated to refining in vitro test methods for dosage forms and drug delivery systems.