A REVIEW: QUALITY BY DESIGN

Akanksha S. More* and Saundarya S. Patil

ABSTRACT

"Quality by Design" (QbD) is the modern approach to pharmaceutical product quality. The excellent calibre of medications is guaranteed by Pharmaceutical Quality by Design, which is covered in this article along with information on it. There is discussion and mention of some of the Quality by Design components. The process variables and quality characteristics of each unit operation are identified. The benefits, options, and procedures for pharmaceutical product quality through design are described. Pharmaceutical development strives to produce a high quality product and its manufacturing process to consistently deliver the product's targeted performance. Although products cannot be quality-checked, quality should be taken into consideration when designing. Important Quality by Design elements, the Quality Target Product Profile, and critical quality attributes are all included. It also contrasts quality by design with end-product testing in terms of product quality. The cornerstone of Quality by Design is the ICH Guidelines. It is based on the ICH Guidelines for Pharmaceutical Quality Systems, Pharmaceutical Development, and Q8, Q9, and Q10, respectively. It also examines the use of Quality by Design in the manufacturing and development of pharmaceutical products.

Keywords: Quality by Design, Quality target product profile, Critical quality attributes, Risk Assessment, Design of Experiments.