Key Information Related to Quality by Design (QbD) Applications in Analytical Methods Development

Author(s):Show less -

Araujo, Alisson Silva ^[1] ; Andrade, Daniel Fernandes ^[1] ; Babos, Diego Victor ^[1] ; Castro, Jeyne Pricylla ^[1] ; Garcia, Jose Augusto ^[1] ; Speranca, Marco Aurelio ^[2] ; Gamela, Raimundo Rafael ^[1] ; Machado, Raquel Cardoso ^[1] ; Costa, Vinicius Camara ^[3] ; Guedes, Wesley Nascimento ^[2] ; Pereira-Filho, Edenir Rodrigues ^[1] ; Verbi Pereira, Fabiola Manhas ^{[2, 4]}

Affiliation

^[1] Univ Fed Sao Carlos UFSCar, Dept Quim, Grp Anal Instrumental Aplicada GAIA, BR-13565905 Sao Carlos, SP - Brazil

^[2] Univ Estadual Paulista Unesp, Inst Quim, Inst Pesquisa Bioenergia IPBEN, Grp Abordagens Analit Alternat GAAA, BR-14800060 Araraquara, SP - Brazil

^[3] Univ Fed Espirito Santo UFES, Dept Quim, LabPetro, Lab Espectrometria Atom LEA, BR-29075910 Vitoria, ES - Brazil

^[4] Inst Nacl Tecnol Alternat Deteccao Avaliacao Toxi, BR-14800060 Araraquara, SP - Brazil

• Document type: Review article
• Source: BRAZILIAN JOURNAL OF ANALYTICAL CHEMISTRY; v. 8, n. 30, p. 14-28, JAN-MAR 2021.
• Web of Science Citations: 0

Abstract

In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production. (AU)

• FAPESP's process: 14/50945-4 - INCT 2014: National Institute for Alternative Technologies of Detection, Toxicological Evaluation and Removal of Micropollutants and Radioactivies
• Grantee: Maria Valnice Boldrin
• Support Opportunities: Research Projects - Thematic Grants
• FAPESP's process: 19/24223-5 - Calibration in Laser-Induced Breakdown Spectroscopy (LIBS): alternatives, challenges, proposals comparison and proposition of a universal procedure
• Grantee: Edenir Rodrigues Pereira Filho
• Support Opportunities: Regular Research Grants
• FAPESP's process: 19/01102-8 - Multi-user equipament approved in grant 2018/18212-8: X-Ray Fluorescence spectrometer
• Grantee: Fabiola Manhas Verbi Pereira
• Support Opportunities: Multi-user Equipment Program
• FAPESP's process: 18/18212-8 - Development of chemometric models for determination of solid impurities in raw sugarcane using energy dispersive X-ray fluorescence
• Grantee: Fabiola Manhas Verbi Pereira
• Support Opportunities: Regular Research Grants