A COMPREHENSIVE UNDERSTANDING ON VARIOUS ASPECTS OF QUALITY BY DESIGN – A REVIEW.
Main Article Content
Keywords
RP-HPLC, Analytical quality by design (AQbD), Central Composite Design, Quality Risk Management
Abstract
Quality by Design (QbD) approach in the pharmaceutical industry which seeks to explore the principles, methodologies, and applications of QbD, and to highlight its significance in ensuring the quality of pharmaceutical products. Today, the new approach to pharmaceutical quality is called Quality by Design. It explains how to apply "Quality by Design" to guarantee pharmaceutical quality. This review identifies some of the components of Quality by Design and describes it. For every unit operation, process parameters and quality attributes are determined. The advantages, prospects, and procedures associated with pharmaceutical product quality by design are explained. The Q8 guidelines for pharmaceutical development, Q9 guidelines for quality risk management, and Q10 guidelines for pharmaceutical quality systems form its foundation. It also discusses the use of Quality by Design in the creation and production of medications. The goal of pharmaceutical development is to create high-quality products and manufacturing processes that reliably produce the desired results. Products cannot be assessed for quality; instead, quality should be included into the design. Key components of Quality by Design, as well as the Quality goal product profile and essential quality criteria, are included. Additionally, it provides a comparison of the product quality as determined by Quality by Design and as determined by final product testing. ICH Guidelines serve as the cornerstone of Quality by Design.
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Nithiyananthan K
Assistant Professor,Adikavi Nannaya University College of Pharmaceutical Sciences,
Tadepalligudem
R.Rekha
Andhra University, Visakapatnam
B.Sravani
Adikavi Nannaya University College of Pharmaceutical Sciences, Tadepalligudem.
G.K.R.Venkata Sumanth
Adikavi Nannaya University College of Pharmaceutical Sciences, Tadepalligudem.
M.Jahnavi
Adikavi Nannaya University College of Pharmaceutical Sciences, Tadepalligudem.
M.Sri Vinay Reddy
Adikavi Nannaya University College of Pharmaceutical Sciences, Tadepalligudem.
P.E.D.Narendra
Adikavi Nannaya University College of Pharmaceutical Sciences, Tadepalligudem.