Risk-based approach for method development in pharmaceutical quality control context: A critical review

被引:101
作者
Deidda, Riccardo [1 ]
Orlandini, Serena [2 ]
Hubert, Philippe [1 ]
Hubert, Cedric [1 ]
机构
[1] Univ Liege ULiege, Lab Pharmaceut Analyt Chem, CIRM, Liege, Belgium
[2] Univ Florence, Dept Chem U Schiff, Via U Schiff 6, I-50019 Florence, Italy
关键词
Analytical quality by design; Design of experiments; Drug analysis; Quality control; Method operable design region; Risk based approach; CAPILLARY-ELECTROPHORESIS METHOD; LIQUID-CHROMATOGRAPHY METHOD; MICELLAR ELECTROKINETIC CHROMATOGRAPHY; PROCESS VARIABLE APPROACH; BY-DESIGN METHODOLOGY; LC METHOD DEVELOPMENT; ICH Q8 DEFINITION; HPLC METHOD; QUANTITATIVE-DETERMINATION; IMPURITIES;
D O I
10.1016/j.jpba.2018.07.050
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Pharmaceutical regulatory bodies increasingly require the implementation of systematic approaches in pharmaceutical product development. Quality control methods play a key role in the control strategy of drugs manufacturing to assure their quality. A risk-based approach in the analytical method development is strongly recommended to ensure that the method performances fit the purpose of the method during its entire life-cycle. In the last decade, analytical quality by design (AQbD), as risk management oriented methodology, has been progressively integrated with method development for fulfilling this objective. This approach has successfully allowed the quality to be designed into the analytical processes by obtaining a deep understanding of the procedures. In this paper the AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed. Recent publications regarding how AQbD has been applied in separation techniques were reviewed. The different development strategies have been also showcased, highlighting their advantages and disadvantages, in order to give a useful overview. (C) 2018 Elsevier B.V. All rights reserved.
引用
收藏
页码:110 / 121
页数:12
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