Analytical Quality by Design; Design Space; Method Operable Design Region (MODR); Risk management; Pharmaceutical impurities; Separative analytical techniques
Abstract :
[en] The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals’ quality and patients’ safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology Chemistry
Author, co-author :
Dispas, Amandine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Avohou, Tonakpon Hermane ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Cédric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances
Publication date :
April 2018
Journal title :
TrAC: Trends in Analytical Chemistry
ISSN :
0165-9936
eISSN :
1879-3142
Publisher :
Elsevier Science, London, United Kingdom
Special issue title :
The Last Decade in Regulation and Control of Impurities in Pharmaceuticals
Volume :
101
Pages :
24-33
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
FEDER - Fonds Européen de Développement Régional [BE] DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
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