New Derivative Spectrophotometric Methods for the Determination of Epalrestat – An Anti Diabetic Drugby Sharath Chandra. Seelam, Dhanalakshmi.K, Nagarjuna reddy, India.

摘要

Quality by Design (QbD) refers to a holistic approach towards drug development. Quality by design is a vital part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and illustrate how it can be used to ensure pharmaceutical quality. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining Quality target product profile, Identifying critical quality attributes, link the drug excipients attributes, establishing design space, control strategy, and product life cycle management. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. A new approach to drug development could increase efficiencies, provide regulatory support and flexibility, and offer important business benefits throughout the product’s life cycle. This article explores the processes used in developing a market formulation and required supportive data, particularly in light of the industry’s current movement toward submissions based on QbD. The work also facilitates the adoption and implementation of QbD. principles in the development of pharmaceutical industries. Successful implementation of QbD concepts requires cooperation across a multitude of company teams, from R&D to manufacturing to quality control and regulatory affairs. This is necessary to ensure that QbD concepts are incorporated not only when the first activities are initiated around a product’s design but also during the design of the process used to make the product and other activities associated with a product’s life cycle. The application of the concept of quality by design (QbD) presented in this paper aligns with the principles of ICH Q8, Q9 and Q10 guidelines.