Instrumental liquid chromatography is an analysis widely used to determine purity, 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 the column,  solvents, and other reagents and chemicals is also an area of focus in an audit.

Areas Covered:-

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
• Sensitivity
• Solution stability
• Accuracy

Background:-

Instrumental liquid chromatography, either as HPLC or UPLC, are a common technique in laboratories that do regulatory-compliance work. 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.

Why Should You Attend:-

In order to meet US EPA or FDA requirements, a method must meet many stringent requirements. The more important of these for specific analytical methods are method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.

Who Will Benefit:-

Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025.