Analytical Quality by Design: A Mini Review
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2017, Vol 1, Issue 6
Abstract
According to ICH Q8 guidelines, QBD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. What is quality by design? QbD incorporates planning, developing formulations and manufacturing procedures which ensures predefined product specifications. In 2002, the FDA announced a new initiative (cGMP for the 21st Century: A Risk based Approach). This initiative intended to modernize the FDAs regulation of pharmaceutical quality, and establish a new regulatory framework focused on QbD risk management, and quality system. The initiative has made the industry to look beyond quality by testing (QbT) for ensuring product quality and performance. An important aspect of QbD is to know how process and formulation parameters could affect the product characteristics and subsequent optimization of these parameters should be known in order to monitor these parameters online in the production process. The use of QbD concepts results in a well-understood product and process that consistently delivers its intended performance. The knowledge acquired during development may support the formation of a design space and determines suitable process controls. These same QbD principles have been applied to the development of analytical methods, and are termed “Analytical QbD” (AQbD). Analogous to process QbD, the result of AQbD is a well understood, fit for purpose, and robust method that consistently delivers the intended performance throughout its lifecycle. The broad knowledge obtained from this process is used to establish a method operable design region (MODR), a multidimensional space based on the method factors and settings that provide suitable method performance. AQbD helps in development of a robust and cost effective analytical method and facilitate the regulatory flexibility in analytical method i.e. the choice to change method parameters within a method’s design space, referred to as the method operable design region (MODR). Regulatory perspective of AQbD Analytical methods are key part of the control strategy in pharmaceutical quality system (ICH Q10). It includes various parameters and attributes related to drug substance and drug product including instrument operating conditions and their associated methods. Though cGMP regulation is in practice from a long time but many pharmaceutical giants are facing quality control related issues that are associated with the risk management system in analytical methods. Therefore looking the dependency of pharmaceutical development and manufacture on robust analytical data, need has come for implementation of AQbD in analytical method development, which is an indicator of quality process, product and robustness throughout the life cycle of the product. Below Figure 1 shows various stages in Qbd/AQbD
Authors and Affiliations
AV Ganorkar, KR Gupta
Keywords
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- EP ID EP572780
- DOI 10.26717/BJSTR.2017.01.000484
- Views 189
- Downloads 0
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