No full text
Unpublished conference/Abstract (Scientific congresses and symposiums)
Implementing principles of Quality by Design (QbD) in validation context
Hubert, Cédric; Lebrun, Pierre; Rozet, Eric et al.
2016Eurachem International Workshop - Method Validation in Analytical Science - Current Practices and Future Challenges
 

Files


Full Text
No document available.
Full Text Parts
160510-Eurachem_Ghent_C.HUBERT.pdf
Author postprint (8.48 MB)
Request a copy
160413-Abstract-C.HUBERT-Eurachem_Ghent.docx
Author postprint (124.11 kB)
Download

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Quality-by-Design; Validation; Quantitative Design Space
Abstract :
[en] Analytical method performances have to be specified by the analyst trough the definition of the “Analytical Target Profile (ATP)”, as proposed by the regulatory bodies. In the specific context of the pharmaceutical industry, regulatory authorities have recently imposed the assessment and management of risk throughout the entire product lifecycle. This includes the analytical procedure and consequently its own lifecycle. The development step of an analytical method is still largely addressed using a “Changing One Separate Factor a Time (COST)” approach (also known as the “Quality-by-Testing (QbT)” approach). This strategy can lead to a suitable method for assessing the risk of routine use, even where the experimental domain is not examined. However, in order to consider an experimental domain rather than a set of specific experimental conditions during the development phase, a multivariate approach must be considered: the “Quality-by-Design (QbD)” strategy. This strategy allows the definition of a “Design Space (DS)” by means of design of experiments (DoE). This DS, computed considering critical method parameters, allows the analyst to focus on the main objective of an analytical method: obtaining reliable results using a robust method. In the course of a specific case study, the benefits of the QbD strategy in terms of managing the qualitative part of the analytical process were highlighted. Working in the context of analytical procedure, the validation step is a major part of the analytical method lifecycle. Indeed, the objective of analytical method validation is to demonstrate that this method is suited for quantifying the target analytes with an established and suitable level of accuracy, as defined by the “ATP”. This is sometimes called the “fit-for-future-purpose” concept. The decision regarding the validity of a method based on prediction can be achieved by using the “β-expectation tolerance interval” (accuracy profile). The capability of this approach to manage the quantitative part of the analytical procedure is nowadays largely illustrated in scientific literatures. Considering the assessment and management of risk throughout the analytical lifecycle, a global strategy allowing the unification of the development and validation phases in a single step was considered. With this innovative approach, a strategy allowing the management of global analytical risk (i.e., for both qualitative and quantitative part of the analytical method) was proposed. Indeed, the developed strategy allows validating an entire experimental domain by means of the accuracy profile rather than a single set of specific experimental conditions. With this strategy, the DS is no longer simply the place where qualitative performances are obtained, but also the space where quantitative performances of the analytical procedure are assessed and managed.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Hubert, Cédric  ;  Université de Liège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ;  Université de Liège > Département de pharmacie > Chimie analytique
Rozet, Eric;  ARLENDA SA
Hubert, Philippe  ;  Université de Liège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Implementing principles of Quality by Design (QbD) in validation context
Publication date :
10 May 2016
Event name :
Eurachem International Workshop - Method Validation in Analytical Science - Current Practices and Future Challenges
Event organizer :
BELAB
Event place :
Ghent, Belgium
Event date :
du 9 mai 2016 au 10 mai 2016
By request :
Yes
Audience :
International
Available on ORBi :
since 11 June 2016

Statistics


Number of views
109 (5 by ULiège)
Number of downloads
23 (2 by ULiège)

Bibliography


Similar publications



Contact ORBi