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

• Main Authors: Alhakeem Maher Abdulrazzaq, Ghica Mihaela Violeta, Pîrvu Cristina Dinu, Anuța Valentina, Popa Lăcrămioara
• Format: Article
• Language: English
• Published: Sciendo 2019-06-01
• Series: Acta Medica Marisiensis
• Subjects: analytical quality by design; lifecycle approach; method operable design region
• Online Access: https://doi.org/10.2478/amma-2019-0010

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.