Abstract

QUALITY BY DESIGN (QBD) HAS BECOME A NEW CONCEPT FOR DEVELOPMENT OF QUALITY PHARMACEUTICAL PRODUCTS

Pooja Suresh Thorat*, Shelke Sumit Ravindra, Shelke Ritesh Shekhar and Vanarase Mayuresh Dilip

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Abstract

The quality by design (QbD) has become a new concept for development of Quality of a new pharmaceutical product, it is an essential part of the modern Approach to pharmaceutical quality, quality by design to ensure quality of Pharmaceuticals. In this review, the quality by design is describe and some of its Elements identified. Process parameter and quality attributes are identified for Each units operation. Benefits, opportunities and step involved in quality by Design of pharmaceutical product are described. It is based on the ICH guideline Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for Pharmaceutical quality system. It also given give application of quality by design in pharmaceutical Development and manufacturing of pharmaceutical. The aim of the Pharmaceutical development is to design a quality product and its Manufacturing process to consistently delivery the intended performance of the Product. Quality cannot be tested into product but quality should be built in by Design. It include the quality target product profile, critical quality attributes and Key aspect of quality by design. It also given comparison between product quality Quality by end product testing and product quality by design.

Keywords: Quality by design(QbD), Target profiling, Critical Quality Attributes, Critical material attribute, Critical proces, Design space.