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Abstract:
Quality by Design (QbD) is a methodology of Pharmaceutical development, recommended by regulatory agencies like USFDA. It has gained more importance in recent times due to the rise in the number of quality issues in pharmaceutical products. QbD helps in building the quality of products by design through risk assessment at the early stage and defining the design space at the later stage. QbD based product development enables the understanding of additional formulation aspects by using a scientific approach and quality risk management. QbD based product development also provides additional assurance to regulatory agencies. The analytical methods which are used for testing of Pharmaceutical drug products are equally important and any design-related issue in the analytical method may create a quality risk for the patients. Even though there is no specific guideline from regulatory agencies on Analytical Quality by design (AQbD), extensive work has been done on this front in the recent past. Application of AQbD in method development aids in ensuring the robustness of the method. This article elaborates on the key elements of Analytical Quality by Design (AQbD) such as the Quality target method profile (QTMP), understanding the critical method parameters (CMP), performing design of experiments (DoE), establishing method sensitivities and control strategies. The analytical methods, developed based on the QbD concept are more robust and reduce the number of Out of trend (OOT) and Out of specification (OOS) results during the actual usage in quality control.
Keywords: AQbD, Method development, DoE, Pharmaceutical development, Control strategy
Introduction
Quality, safety, and efficacy of pharmaceutical products have been the prime focus for regulatory agencies such as the United States food and drug administration (USFDA), and Medicines and Healthcare Products Regulatory Agency (MHRA). The recent recalls and warning letters have amplified the surmise on the quality of the drug products and resulted in a higher level of scrutiny by the regulators. Various guidelines (Q8, Q9, Q10, Q11, and Q12) have been introduced by ICH on the implementation of Quality by design (QbD) and PAT tools [1]. The quality of the pharmaceutical products can not solely be controlled by testing, instead it is expected to be built in by design. As per ICH guideline, Pharmaceutical Development Q8 (R2), "Pharmaceutical development is aimed at designing a...