The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals' quality and patients' safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods.

制药行业受到质量政策的严格监管。风险管理的概念已牢固地集成到质量保证体系中，以确保药品的质量和患者的安全。在质量控制的背景下，原材料和成品中杂质的检测是一个主要问题。对于分析科学家来说，要满足特异性/选择性和敏感性要求可能是具有挑战性的。显然，分离技术已广泛用于杂质的检测，但是实现分析目标轮廓（ATP）问题所需的方法开发通常具有挑战性。因此，为了确保开发实用和系统的方法并同时管理与分析方法相关的风险，应采用“设计质量”（QbD）原则。