Established Conditions in Analytical Procedure: Overview, Regulatory Examples and an FDA Laboratory Study

Established conditions (ECs) are manufacturing and control elements considered necessary to assure product quality (e.g., ECs in manufacturing process) and to help assure method performance (e.g., ECs in analytical procedures). ECs in analytical procedures help to maintain reliable results that can ensure the efficient product control strategy during the product life cycle. Changing ECs in analytical procedures may necessitate a certain level of regulatory activity and the level of regulatory activity can be different depending on the strategy defining ECs and the extent of changes. The presentation will first provide a high-level overview of harmonized scientific risk-based approaches for identifying ECs and determining the corresponding reporting categories based on scientific principles described in ICH Q12 and Q14 guidelines. Then, two regulatory examples involving ECs in analytical procedures will be discussed. It is noteworthy mentioning that both parameter and performance-based ECs in an analytical procedure are defined in these two examples. The last part of the presentation will be an FDA laboratory study on a mass spectrometry method for a recently identified NDSRI (Nitrosamine drug substance-related impurity). In this case study, analytical variables and method robustness were investigated according to recommendations from the ICH Q2R2 (draft) Guideline. Based on the impact of each variable on method performance, categorical and numerical ECs were proposed.

Presented by Jinhui Zhang, Chemist at FDA/CDER

Dr. Jinhui Zhang is a Chemist at the FDA/CDER. His research at FDA focuses on using advanced mass spectrometry and automation platforms for the characterization of biotherapeutics, complex drug products and clinical studies.

Prior to joining FDA, he held a research faculty position at Texas Tech University. He has given 60 invited podium presentations and published 50 peer reviewed publications on drug products quality, pharmacokinetics, bioanalysis, pharmacogenomics and omics based therapeutic biomarkers.

Dr. Zhang is an editorial advisory board member of Bioanalysis, an organizing committee member of CASSS DC Discussion Group.

Followed by Dimple Shah, Pr. Scientist at Waters Corporation

Dimple Shah has a M.S. degree in Organic Chemistry from St. Xavier’s college, Gujarat University, India. She also has a M.S. degree in Chemistry from University of Massachusetts at Lowell.  She is working at Waters Corporation, Milford as a Principal Scientist in Genotoxic impurity and Food and Environment market. She is responsible for development of analytical methods for determination of NDSRI for genotoxic impurity market and contaminants in food and water using LC and Mass spectrometers. Her areas of expertise are LC, tandem quadruple, high resolution mass spectrometry and various chromatographic and mass spectrometry software.  She has published several application notes on NDSRI, polar pesticides, pesticides, veterinary drugs, mycotoxins, sugars, sweeteners, vitamins and dyes.

Followed by Dr. Phil Koerner, Global Pharmaceutical Market Development Manager at Phenomenex

Dr. Phil Koerner is the Global Pharmaceutical Market Development Manager with Phenomenex, a Danaher Company, located in Torrance, California. In this role he is accountable for developing, communicating, and leading strategic initiatives and integrated marketing programs to support the pharmaceutical industry. Prior to his current role with Phenomenex, he travelled globally sharing his expertise and experience with customers through technical seminars and hands-on training covering topics in HPLC, GC, and sample preparation. He has also been an instructor for USP courses on General Chapters <467> (Residual Solvents) and <621> (Chromatography).

Sponsored by Waters Corporation and Phenomenex

About Waters Corporation

Waters Corporation, with over 60 years of pioneering expertise, is a global leader in analytical instruments and software, specializing in liquid chromatography, mass spectrometry, and thermal analysis.

Our commitment to innovation drives us to provide state-of-the-art solutions for the most challenging analytical needs. In response to the rising concern over nitrosamines in pharmaceuticals, food, and environmental samples, Waters offers cutting-edge technologies and comprehensive methodologies designed to ensure accurate detection and quantification of these contaminants.

Our ACQUITY™ and Xevo™ portfolios are renowned for their precision, sensitivity, and robustness, enabling researchers and quality control laboratories to meet stringent regulatory requirements with confidence. Backed by our dedicated team of scientists and support professionals, Waters delivers unparalleled service and expertise to our clients worldwide.

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About Phenomenex

Phenomenex is a leader in chromatography and sample preparation products for research across multiple industries including clinical,forensics and toxicology, food, enviromental and industrial. Our GC and LC columns, sample extraction consumables, accessories and technical literature provide method development solutions for analysis of PFAS and environmental contaminants, prescribed and illicit drugs, hormones, vitamins, and other biomarkers. Our team of dedicated scientists can provide technical support and consultation for successful method development, troubleshooting, and training.