A Review on Quality by Design Approach in Analytical Methods

  • Vinayak Katekar Department of Quality Assurance, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India
  • Dipali Sangule Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India
  • Om Bhurbhure Department of Pharmaceutics, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India
  • Priyanka Ingle Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India
  • Shivprasad Dhage Department of Pharmaceutics, Pataldhamal Wadhwani College of Pharmacy, Yavatmal, 445001 (MS), India
  • Krushna Jadhav Department of Pharmaceutics, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik (MS), India

Abstract

Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. All conventional methods may fail to the intended purpose during method development and validation. In a QbD approach, the impact and interactions between critical method variables are understood using a Design of Experiments (DOE) approach, which gives multivariate analysis and modeling leading to the consistent quality of drug products. QbD tools like risk assessment and design of experiments, enable better quality to be incorporated into the analytical method and facilitate prior understanding and identification of variables affecting method performance. The main objective of the present review article is to describe different steps involved in method development by the QbD approach for analytical method development. The QbD Approach for method development comprises various steps that include defining method intent, performing experimental design, evaluating experimental results, selecting proper method conditions, and performing risk assessment with changing analytical parameters and conditions for evaluation. The purpose of analytical QbD is to attain quality in measurement.

Keywords: Quality by Design (QbD), Design of Experiments (DOE), Critical attributes

Keywords: Quality by Design (QbD), Design of Experiments (DOE), Critical attributes

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Author Biographies

Vinayak Katekar, Department of Quality Assurance, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India

Department of Quality Assurance, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India

Dipali Sangule, Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India

Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India

Om Bhurbhure, Department of Pharmaceutics, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India

Department of Pharmaceutics, Smt. Kishoritai Bhoyar College of Pharmacy, Kamptee, Nagpur (MS), India

Priyanka Ingle, Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India

Department of Quality Assurance, Anuradha College of Pharmacy, Chikhli (MS), India

Shivprasad Dhage, Department of Pharmaceutics, Pataldhamal Wadhwani College of Pharmacy, Yavatmal, 445001 (MS), India

Department of Pharmaceutics, Pataldhamal Wadhwani College of Pharmacy, Yavatmal, 445001 (MS), India

Krushna Jadhav, Department of Pharmaceutics, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik (MS), India

Department of Pharmaceutics, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik (MS), India

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How to Cite
1.
Katekar V, Sangule D, Bhurbhure O, Ingle P, Dhage S, Jadhav K. A Review on Quality by Design Approach in Analytical Methods. JDDT [Internet]. 15Jun.2022 [cited 1Jul.2022];12(3-S):255-61. Available from: https://jddtonline.info/index.php/jddt/article/view/5386

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