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Tony Taylor is Group Technical Director of Crawford Scientific Group and CHROMacademy. His background is in pharmaceutical R&D and polymer chemistry, but he has spent the past 20 years in training and consulting, working with Crawford Scientific Group clients to ensure they attain the very best analytical science possible. He has trained and consulted with thousands of analytical chemists globally and is passionate about professional development in separation science, developing CHROMacademy as a means to provide high-quality online education to analytical chemists. His current research interests include HPLC column selectivity codification, advanced automated sample preparation, and LCâMS and GCâMS for materials characterization, especially in the field of extractables and leachables analysis.

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The new General Chapter <621> does reflect the great work of the Pharmacopoeias in helping chromatographers to use more modern technology for their regulated methods, speeding up analysis, and reducing waste. The latest revision allows us to adjust column dimensions for gradient separations, which is a significant advance. Although these freedoms are welcomed, one must be very mindful of the requirements or limits of the allowable changes and the verification work that underpins our demonstration of equivalent performance of the adjusted method.

Allowable Changes to Chromatography Methods for HPLC – More Freedom for Chromatographers Granted by the Pharmacopeias?

Kevin A. Schug is a Full Professor and Shimadzu Distinguished Professor of Analytical Chemistry in the Department of Chemistry & Biochemistry at The University of Texas (UT) at Arlington. He joined the faculty at UT Arlington in 2005 after completing a Ph.D. in Chemistry at Virginia Tech under the direction of Prof. Harold M. McNair and a post-doctoral fellowship at the University of Vienna under Prof. Wolfgang Lindner. Research in the Schug group spans fundamental and applied areas of separation science and mass spectrometry. Schug was named the LCGC Emerging Leader in Chromatography in 2009, and most recently has been named the 2012 American Chemical Society Division of Analytical Chemistry Young Investigator in Separation Science awardee.

The lack of proper method validation has important implications in blood alcohol concentration (BAC) determinations. We examine this issue, addressing the importance of gas chromatography (GC) for BAC determination, why certain validation procedures are important, and why accreditation bodies need to step up their game.

Accredited Forensics Laboratories Are Not Properly Validating and Controlling Their Blood Alcohol Determination Methods

 is Business Unit Manager of Eurofins BioPharma Product Testing in Toronto, Canada. Doug has over 30 years of experience in pharmaceutical R&D and analytical testing in both large pharma and contract research organizations. Doug received a Doctor of Philosophy degree in analytical neurochemistry from the University of Oklahoma in Norman, Oklahoma, USA, as well as a B.Sc. degree (honours) in chemistry and an M.Sc. degree in analytical chemistry, both from McGill University in Montreal, Canada.

 is Research and Development Manager at Eurofins BioPharma Product Testing Laboratories. Uttam is responsible for all R&D activities at Eurofins, including method development, method transfer, and validation efforts. Uttam has over 12 years of experience in the pharmaceutical industry, including comprehensive knowledge and implementation of current GMP, GLP, FDA, and CFR 21 Part 11 regulations. Uttam obtained his M.Sc. degree in analytical chemistry from Kingston University, UK.

 is the manager of Waters’ global small molecule pharmaceutical market segment, with 20+ years of experience in product and segment marketing. Stephanie has a passion for enabling world-class pharmaceutical development and has been instrumental in helping customers to transform the way their organizations operate. She is a highly cited author with a Ph.D. in chemistry from the University of Bristol, UK.

The advantages of a risk-based approach to instrument replacement are discussed.

Application of a Risk‑Based Approach to the Migration of Validated Test Methods

Change, while scary, is a necessity. Opportunities for increased efficiency, higher profitability, and the ability for an organization to maintain a competitive advantage necessitate the need for change. Correctly adopting new liquid chromatography (LC) technology can be very challenging, however, when done correctly, modern LC technology can give a laboratory the ability to simplify method transfer across a diversity of analytical LC platforms at all of its facilities.

Modernizing, Managing, and Complying with Regulatory Advances in Science

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

The first three articles in this series discussed where and how a CDS fits into a regulated laboratory, the overall requirements for the architecture of a future system, and additional items to enable effective electronic ways of working. The final part of this series looks at regulatory compliance of a future system as well as a summary of the 15 recommendations made in this series.

The Ideal Chromatography Data System for a Regulated Laboratory, Part IV: Assuring Regulatory Compliance

Polystyrenes (PS) are the most commonly used reference standards in gel permeation chromatography/size-exclusion chromatography (GPC/SEC) for nearly all organic GPC/SEC separations including high temperature GPC and pullulan or dextran for aqueous GPC/SEC. The majority of users rely on these standards for reproducible results. However, there is potential for improvements and this instalment of Tips & Tricks will discuss some general points that should be considered when determining calibration standards.

Tips & Tricks GPC/SEC: Finding the Right Standards

The fate and modification of nanoparticles in real life matrices can be investigated by the combination of field-flow fractionation (FFF) with inductively coupled plasma mass spectrometry (ICP–MS). This article explains more.

Nanoparticle Toxicity: Responding to Analytical and Regulatory Challenges with Field-Flow Fractionation

Calibration using broad standards in GPC/SEC is discussed.

Tips & Tricks GPC/SEC: Calibration Using Broad Standards

Quality Control of Dietary Supplements - Chromatographic Approaches for CGMP Compliance

The National Institute of Standards and Technology (NIST), an agency of the U.S. Department of Commerce, has made a polycyclic aromatic hydrocarbon (PAH) structure index database publicly available on-line (http://pah.nist.gov/). A byproduct of hydrocarbon fuel combustion, PAHs can have significant adverse health and environmental impacts. The website contains data on more than 650 PAH compounds, with more to be added in the future.

Regulatory Standards, GLP and GMP Compliance | Topics