Navigating the AQbD Landscape: Enhancing Quality Management in Liquid Chromatography Method Development

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2025-02-22 DOI:10.1002/bmc.70031

Selvakumar Kanthiah, J. Joysa Ruby, Hiriyanna SGB, Valliappan Kannappan

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引用次数: 0

Abstract

The implementation of ‘Analytical Quality by Design’ (AQbD) is currently recognised as a methodical and scientific approach to liquid chromatographic (LC) method development. It begins with defining the Analytical Target Profile (ATP), identifying Critical Method Parameters (CMPs) and Critical Quality Attributes (CQAs) or responses. This process also includes risk assessment study by Design of Experiment (DoE) and to optimise LC effectively. The next step is to create an analytical design space and implement a control strategy that will allow for continuous method improvement over the life of the method. Understanding the AQbD principles, methodologies, techniques and applications towards the high-performance liquid chromatography (HPLC) method lifecycle is considered as essential in today's pharmaceutical landscape. As industry demands for quality assurance and regulatory compliance, this review paper briefly discusses the AQbD principles and methodology in HPLC method lifecycle. Also, the paper covers AQbD components such as identification of ATP, CQA, MODR (method operable design region), control strategies and continuous method monitoring. In addition, it also covers regulatory perspectives on AQbD, obstacles and potential outcomes in the development of pharmaceutical analytical methods. These aspects provide valuable insights into the application of AQbD in the field of LC.

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导航AQbD景观：加强液相色谱方法开发中的质量管理

实施“设计分析质量”（AQbD）目前被认为是液相色谱（LC）方法开发的一种系统和科学的方法。首先定义分析目标概要（ATP），确定关键方法参数（cmp）和关键质量属性（cqa）或响应。该过程还包括实验设计（DoE）的风险评估研究和有效优化LC。下一步是创建一个分析设计空间，并实施一个控制策略，以允许在方法的生命周期内持续改进方法。了解AQbD的原理、方法、技术和在高效液相色谱（HPLC）方法生命周期中的应用在当今的制药领域被认为是必不可少的。根据行业对质量保证和法规遵从性的要求，本文简要讨论了HPLC方法生命周期中的AQbD原则和方法。此外，本文还涵盖了AQbD的组成部分，如ATP的识别、CQA、MODR（方法可操作设计区域）、控制策略和连续方法监测。此外，它还涵盖了AQbD的监管观点，药物分析方法发展中的障碍和潜在结果。这些方面为AQbD在LC领域的应用提供了有价值的见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.