<abstract xmlns="http://www.w3.org/1999/xhtml"><p>Quality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the AQbD. Inside the method operable design region (MODR), the AQbD permits the movements of the analytical methods. This paper has been produced to discuss various views of analytical scientists, the comparison with conventional methods, and the phases of the analytical techniques.</p></abstract>

Quality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the AQbD. Inside the method operable design region (MODR), the AQbD permits the movements of the analytical methods. This paper has been produced to discuss various views of analytical scientists, the comparison with conventional methods, and the phases of the analytical techniques.

Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

University of Medicine and Pharmacy “Carol Davila”

Department of Physical and Colloidal Chemistry, Faculty of Pharmacy

Acta Marisiensis - Seria Medica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Quality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of...

Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

Publicado en línea: 04 jul 2019

Páginas: 37 - 44

Recibido: 04 feb 2019

Aceptado: 23 may 2019

DOI: https://doi.org/10.2478/amma-2019-0010

Palabras clave
analytical quality by design, lifecycle approach, method operable design region

© 2019 Maher Abdulrazzaq Alhakeem et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

Publicado en línea: 04 jul 2019

Páginas: 37 - 44

Recibido: 04 feb 2019

Aceptado: 23 may 2019

DOI: https://doi.org/10.2478/amma-2019-0010

Palabras claveanalytical quality by design, lifecycle approach, method operable design region

© 2019 Maher Abdulrazzaq Alhakeem et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Palabras clave
analytical quality by design, lifecycle approach, method operable design region