Division of Product Quality Research, Office of Testing and Research, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
Division of Post-Marketing Activities I, Office of Lifecycle Drug Products, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
J Pharm Sci. 2024 Oct;113(10):3028-3033. doi: 10.1016/j.xphs.2024.07.022. Epub 2024 Aug 5.
With the finalization of the ICH Q14 Analytical Procedure Development guideline, how to apply enhanced approaches (such as analytical quality by design (AQbD)) to develop an analytical procedure, and to propose Established Conditions (ECs) and corresponding reporting categories, is increasingly being discussed. To gain practical experience in applying an enhanced approach for method development and identifying ECs, we developed, validated, and implemented an analytical procedure for a nitrosamine drug substance-related impurity (NDSRI). Here, as an example of the application of Q12 Lifecycle Management guideline principles in regards to analytical procedures, we briefly elaborate how: 1) the principles documented in the ICH Q14 guideline for analytical procedure development were applied, with the focus on identifying an Analytical Target Profile (ATP), knowledge management and risk assessment; 2) analytical procedure robustness according to the recommendations in ICH Q2(R2) Validation of Analytical Procedure guideline and Q14, were evaluated; and 3) mass spectrometry ECs and associated proposed reporting categories were proposed.
随着 ICH Q14 分析程序开发指南的最终确定，如何应用增强型方法（如分析质量源于设计（AQbD））来开发分析程序，并提出既定条件（ECs）和相应的报告类别，越来越多地受到讨论。为了在方法开发和确定 ECs 方面获得应用增强型方法的实际经验，我们开发、验证和实施了一种用于亚硝胺药物相关杂质（NDSRI）的分析程序。在这里，作为应用 ICH Q12 生命周期管理指南原则的一个例子，我们简要阐述了如何：1）应用 ICH Q14 分析程序开发指南中记录的分析程序开发原则，重点是确定分析目标概况（ATP）、知识管理和风险评估；2）根据 ICH Q2(R2) 分析程序验证指南和 Q14 的建议评估分析程序稳健性；3）提出质谱 ECs 及其相关建议的报告类别。
