Key Elements of HPLC and UPLC Method Validation to Ensure Compliance with FDA and ISO Requirements
- Product Id : FDB3461
- Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics
- Presenter : Dr. John C. Fetzer
- Duration : 60 Minutes
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.
- Instrument validation
- The pumping system
- The column
- The detection system
- The Data System
- Method validation
- Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
- Limits of detection and quantitation, linearity
- Selectivity, interferences, and specificity
- Solution stability
- Laboratory Assistants
- QA Managers and Personnel
- QC Managers and Personnel
- Validation Specialists
- Quality System Auditors
- Regulatory Compliance Associates