Abstract

REVIEW ON: QUALITY BY DESIGN [QBD]

S. A. Awachar* and S. C. Kale

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Abstract

Quality by design (QbD) is an important factor in today's pharmaceutical quality advancements. All regulatory bodies for pharmaceuticals put an emphasis on quality. Customer satisfaction in terms of service, goods, and procedures is defined as quality. QbD is the most effective way to ensure that all pharmaceutical items are of high quality. This article discusses Pharmaceutical Quality by Design (QbD) and how it may be used to assure the quality of pharmaceutical analysis. It involves developing and improving formulations and manufacturing methods in order to meet predetermined product quality standards. Defining quality target product profile, identifying essential quality characteristics, linking the drug excipients' qualities, establishing design space, control strategy, and product life cycle management are just a few of the QbD features. Pharmaceutical quality may be ensured through QbD by understanding and regulating formulation and production factors. A novel method of drug development might boost productivity, give regulatory backing and flexibility, and bring significant economic benefits throughout the product's life cycle. This article looks at the steps involved in creating a market formulation and the supporting data needed, especially in light of the industry's recent shift to submissions based on QbD. The study also helps in the acceptance and application of QbD concepts in the pharmaceutical industry's development. Collaboration across a variety of corporate departments, from R & D to production to quality control and regulatory affairs, is required for the successful implementation of QbD principles. This is designed to assure that QbD principles are implemented not only when the first activities around a product's design are begun, but also during the design of the manufacturing process and other activities related to the product's life cycle. The ideas of the ICH Q8, Q9, and Q10 guidelines are aligned with the application of the principle of quality by design (QbD) presented in this paper.

Keywords: control strategy, critical material attributes, critical process parameters, design space, Quality by design.