QBD BASED ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TEST METHOD AS PER ICH Q2 (R1): A Review
Author(s):
Ayushi Kumawat, Dr. Anju goyal, Dr. Hemendra Pratap Singh
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.
Article Details
Unique Paper ID: 159547

Publication Volume & Issue: Volume 9, Issue 12

Page(s): 143 - 148
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