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.
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.
Dr. John C. Fetzer, PhD offers over 20 years of expertise in Analytical Chemistry, focusing on Polycyclic Aromatic Hydrocarbons, Petroleum and its Products, Chromatography, and UV and Fluorescence Spectroscopy. He offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services to companies, organizations, and individuals. Dr. Fetzer has over a decade of experience as a supervisor, team leader, trainer, and coach. He has published over 100 peer-reviewed scientific publications, 2 books, and 8 book chapters.
Dr. Fetzer is an American Chemical Society tour speaker, who has participated in over twenty invited lectures at conferences, universities, and government laboratories.