Instrumental liquid chromatography, either as HPLC or UPLC, is 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.
Instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most UPLC and HPLC 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.
In order to meet GLP guidelines or FDA requirements, a method must meet many stringent requirements. The more important of these for specific analytical methods are HPLC and UPLC method validation and instrument validation. To not do so is a non-compliance in which any data is not usable or reportable.
Learn about the specific instrumental issues in UPLC and HPLC method validation.
Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025.
Years of Experience: 30+ years
Areas of Expertise: Chromatography, Analytical Chemistry and Bioanalytical Chemistry
John C. Fetzer is an expert on petroleum, its composition, the composition of its many products – light hydrocarbon gases (natural gas, methane, liquefied petroleum gas), gasoline, diesel fuel, jet fuel, kerosene, naphtha, mineral and lubricating oils, wax, asphalt, petroleum coke). He is an accomplished analytical chemist and expert in chromatography and molecular spectroscopy (infrared, ultraviolet absorbance, fluorescence, mass spectrometry, and nuclear magnetic resonance spectrometry). In that role he developed several Good Laboratory Practices compliant chromatography methodologies, as well as ones to determine octanol-water partition coefficients and to determine solubilities in water and other solvent systems.
He managed a section comprising 6 chromatography laboratories – over 120 chromatographs and 38 people. These laboratories maintain GLP compliance, including implementation of numerous new methodologies. He has been an instructor in statistics as used in the laboratory and on compliance for well over 25 years.
He is a recognized world-class expert in the chemistry and analysis of the polycyclic aromatic hydrocarbons (PAHs). He has over 100 reviewed publications and numerous book chapters, and authored the books The Chemistry and Analysis of the Large Polycyclic Aromatic Hydrocarbons, J. C. Fetzer, John Wiley and Sons, New York, p. 1-288 (2000) and Career Management for Chemists, Springer-Verlag, Berlin, p. 1 -266 (2004).
He worked for a major petroleum company for over two decades before founding his own consulting company. He has served on the editorial advisory boards of Analytical Chemistry, the Journal of Chromatography, Analytical and Bioanalytical Chemistry (Springer-Verlag), and Polycyclic Aromatic Compounds. The 2005 Erich Clar Award of the International Society for Polycyclic Aromatic Compounds (ISPAC) was given to Dr. Fetzer for his variety of research achievements on the large PAHs. He has served as secretary and president of ISPAC.View all trainings by this speaker