Analytical Procedure Validation and the Quality by Design Paradigm

[en] Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach. While development and optimization of analytical procedure following QbD principles have been largely discussed and described, the place of analytical procedure validation in this framework has not been clarified. This article aims at showing that analytical procedure validation is fully integrated into the QbD paradigm and is an essential step in developing analytical procedures that are effectively fit for purpose. Adequate statistical methodologies have also their role to play: such as design of experiments, statistical modelling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.

Disciplines :

Mathematics
Physical, chemical, mathematical & earth Sciences: Multidisciplinary, general & others

Author, co-author :

Rozet, Eric ; Arlenda / Université de Liège > Département de pharmacie > Chimie analytique

Lebrun, Pierre ; Arlenda / Université de Liège > Département de pharmacie > Chimie analytique

Michiels, Jean-François; Arlenda

Sondag, Perceval; Arlenda

Scherder, Tara; Arlenda Inc.

Boulanger, Bruno ; Arlenda / Université de Liège > Département de pharmacie > Département de pharmacie

Language :

English

Title :

Analytical Procedure Validation and the Quality by Design Paradigm

Publication date :

2015

Journal title :

Journal of Biopharmaceutical Statistics

ISSN :

1054-3406

eISSN :

1520-5711

Publisher :

Taylor & Francis, Philadelphia, United States - Pennsylvania

Volume :

Pages :

1-9

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 28 January 2015

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