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From concept to compliance: The role of QbD in modern product development

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Review Article

Author Details : Prafull P. Mane, Firoj A. Tamboli*, Rakesh B. Babaleshwar, Dnyaneshwar M. Mane, Parvej S. Attar, Pratik P. Disale, Pranoti A. Patil, Shweta M. Parkhi, Mohan P Rathod

Volume : 6, Issue : 4, Year : 2024

Article Page : 168-175

https://doi.org/10.18231/j.ctppc.2024.032

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Abstract

Pharmaceutical development is revolutionized by the Quality by Design (QbD) strategy, which replaces conventional trial-and-error procedures with a systematic, science-based approach that ensures product quality, safety, and efficacy. This article offers a comprehensive description of the key elements and instruments required to execute QbD, as specified by regulatory recommendations like ICH Q8 (R2) and ICH Q9. The construction of a Target Product Quality Profile (TPQP), which acts as a dynamic summary of the quality attributes required to achieve the intended product quality, safety, and efficacy, is the basic concept of quality-based development (QbD). Critical quality attributes, or CQAs that are, are important qualities that need to be maintained within specified limits in order to ensure the quality of the final product. These are connected to Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) via risk assessment techniques like Fault Tree Analysis (FTA) and Failure Mode Effects Analysis (FMEA). An essential component of Quality-Based Development (QbD) is Quality Risk Management (QRM), which offers a framework for evaluating and controlling risks over the course of a product's existence. To identify and reduce potential risks, a variety of tools are used, such as Hazard Analysis and Critical Control Points (HACCP), FMEA, and FTA. The foundation of Quality-Based Design (QbD) is the idea of Design Space, which is described as the multifaceted collection of variable inputs and process factors that ensures quality assurance. Another crucial element of QbD is Control Strategy, which consists of a series of planned controls based on knowledge about present products and processes. The concepts of lifecycle management and continuous improvement highlight the significance of implementing a pharmaceutical quality system at every stage of the product lifecycle in order to encourage innovation and continuous improvement while assuring regulatory compliance. The principles of Quality by Design (QbD) are applied with the use of several technologies, including Process Analysis Technologies (PAT) and Design of Experiments (DOE). These technologies allow for the real-time monitoring and management of critical process parameters, which reduce manufacturing unpredictability and increase product quality.

Keywords: Quality-Based Design (QbD), Design of Experiment (DoE), Quality risk management (QRM), Design Space (DS), Control Strategy (CS), Process Analytical Tool (PAT)

How to cite : Mane P P, Tamboli F A, Babaleshwar R B, Mane D M, Attar P S, Disale P P, Patil P A, Parkhi S M, Rathod M P, From concept to compliance: The role of QbD in modern product development. Curr Trends Pharm Pharm Chem 2024;6(4):168-175

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