Fusion LC Method Validation™
Automated LC Method Validation Software
Works with Waters® and Agilent LC Systems controlled by:
- Waters Empower™ (1 and 2) Chromatography Data Software(CDS)
- Agilent Chemstation® and Galaxie® CDS
- Dionex® Chromeleon® Chromatography Data Software (CDS)
PhRMA's Analytical Technical Group recommends a phased approach to analytical method validation in which early phase validation efforts are done upstream on a reduced set of validation elements appropriate to the stage of development.
Early Phase Method Validation (Characterization)
Fusion Method Validation™ (FMV) offers Early Phase experiments structured for internal consumption to support and guide method development.
- Analytical Capability and System Suitability
- Specificity
- Filter Validation
- Accuracy
- Linearity and Range
- LOQ, LOD
- Repeatability* (intra-assay precision)
- Sample Solution Stability (stability for a given time period under prescribed conditions)
Final Phase Method Validation (FDA and ICH Submittal Quality)
FMV offers Final Phase experiments structured with the rigor and regulatory compliance overlay required of results that may be exported outside the lab.
- Analytical Capability and System Suitability
- Specificity
- Accuracy/Linearity and Range/Repeatability – Combined Design (ICH-Q2A states that Accuracy, Linearity, and Repeatability can be combined into a single experiment)
- LOQ, LOD
- Intermediate Precision and Reproducibility (USP Ruggedness)
- Robustness
Phase 2 — Robust Method Development and Optimization
FMD brings a new QbD-based methodology to formal HPLC method development. Regulatory guidances state that the best-practices approach should address robustness during formal method development. Therefore, a critical feature of FMD is the patented Robustness Simulator™ technology (U.S. Patent No. 7,606,685 B2), which integrates automatically computed method robustness metrics for all Critical Quality Attributes (CQA) studied, into method development experiments. This novel methodology automates a best-practices approach in which HPLC methods can be rapidly developed and simultaneously optimized for mean chromatographic performance and robustness.
Pharma Customer Benchmarking
To benchmark time savings using FMV versus current practice, a senior analytical chemist at an international pharmaceutical account used FMV to complete a series of Early Phase and Final Phase method validation experiments. The entire method validation exercise took less than 12 hours using Fusion AE.
Work records showed that on average — from SOP planning and experiment design construction to final reporting — using "current practice" this project would have required more than two weeks of analyst time.
