QBD BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TEST METHOD AS PER ICH Q2 (R1): A Review

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Ayushi Kumawat; Dr. Anju goyal; Dr. Hemendra Pratap Singh

QBD BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TEST METHOD AS PER ICH Q2 (R1): A Review

Authors: Ayushi Kumawat, Dr. Anju goyal, Dr. Hemendra Pratap Singh

Unique Paper ID: 159547
Volume: 9
Issue: 12
PageNo: 143-148

Keywords: Quality by Design Analytical Quality by Design Method Development Method Validation ICH

Abstract:
Analytical Quality by Design, or AQbD, is the term used to describe the concept of QbD to the development of analytical methods. Analytical quality by design (AQbD) is a practise used informally in the pharmaceutical industry as a component of risk management, pharmaceutical development, and pharmaceutical quality system. Regulatory bodies receive more assurance from QbD-based product development. The analytical techniques that are used to analyse pharmaceutical products are equally vital, and any problems with the analytical technique's design might put patients at risk for poor quality care. Despite the fact that there isn't a specific regulatory agency directive on analytical quality by design (AQbD), a lot of work has been done recently in this area. The use of AQbD in method development helps to ensure the method's resilience. Regulation-related suggestions for pharmaceutical development have been released by the International Conference for Harmonisation (ICH). The main tenets of Analytical Quality by Design (AQbD) are discussed in detail in this article, including the Quality Target Method Profile (QTMP), Critical Method Parameters (CMP), Design of Experiments (DoE), and Method Sensitivity and Control Strategies.

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Cite This Article

ISSN: 2349-6002
Volume: 9
Issue: 12
PageNo: 143-148

QBD BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TEST METHOD AS PER ICH Q2 (R1): A Review

Available:https://ijirt.org/article?manuscript=159547

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8.01 (Year 2024)

UGC Approved
Journal no 47859

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