Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

IF 0.8 4区工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-05-13 DOI:10.1007/s00769-024-01587-w

Kiranmayi Sathuluri, RamyaSri Bakam, Riya Jain, Aishwarya Dande, Rahul Gajbhiye, V. Ravichandiran, Ramalingam Peraman

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Abstract

Analytical quality by design (AQbD) is one of the risk-based approach used to develop robust analytical method in compliance with regulatory requirements. The concept of AQbD was recently established in the literature and has proven advantages in the pharma industries. Despite the differential view on AQbD, the International Council for Harmonization (ICH) has released the ICHQ14 document for analytical procedure development. Notably, the enhanced approach of the ICHQ14 document mimics AQbD workflows in analytical procedure development. Among ICHQ14 recommendations, the need for knowledge assessment, multivariate models for proven acceptable range (PARs) as method operable region, sample suitability assessment in robustness, and real-time release testing with product critical quality attribute specifications as the challenging components for pharmaceutical industries. In addition, the integration of ICHQ14 with other ICH documents like ICH Q6A/6B, ICHQ8, ICHQ9, ICHQ10, ICHQ11, and ICHQ12 are well defined in the document. Thus, the revised ICHQ2 (R2) guideline has defined the validation procedure with integration to ICHQ14 documents.

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ICHQ14 分析程序开发指南中的设计分析质量（AQbD）

设计分析质量（AQbD）是一种基于风险的方法，用于开发符合法规要求的可靠分析方法。AQbD的概念是最近在文献中建立的，并且在制药行业中已被证明具有优势。尽管对AQbD有不同的看法，但国际统一理事会（ICH）已经发布了ICHQ14文件，用于分析程序的开发。值得注意的是，ICHQ14文档的增强方法模拟了分析程序开发中的AQbD工作流程。在ICHQ14的建议中，知识评估的需求，证明可接受范围（par）的多变量模型作为方法可操作区域，稳健性的样本适用性评估，以及产品关键质量属性规范的实时释放测试作为制药行业的挑战性组件。此外，ICHQ14与ICH Q6A/6B、ICHQ8、ICHQ9、ICHQ10、ICHQ11、ICHQ12等其他ICH文档的整合在文档中也有很好的定义。因此，修订后的ICHQ2 （R2）指南定义了与ICHQ14文件集成的验证程序。

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来源期刊

Accreditation and Quality Assurance 工程技术-分析化学

CiteScore

1.80

自引率

22.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.