Instrumental Issues in GC and GC-MS for On-Going Validation

Instrumental gas chromatography as an analysis is 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.

Instrumental gas chromatography, either as GC or GC-MS, are common techniques 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 You Should 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.

Areas Covered in the Session :

• The injector
• The column
• The interface
• The detection system
• The data system
• Symptoms to monitor
• The use of control charts to ensure compliance

Who Should Attend:

• Chemist
• Laboratory Assistants
• QA Managers and Personnel
• QC Managers and Personnel
• Validation Specialists
• Quality System Auditors
• Regulatory Compliance Associates