title: Analytical procedure validation and the quality by design paradigm.
abstract: 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 modeling, and probabilistic statements. The outcome of analytical procedure validation is also an analytical procedure design space, and from it, control strategy can be set.
authors.affiliation: a Arlenda S.A. , Liège , Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Rozet
authors.forename: Pierre
authors.initials: P
authors.lastname: Lebrun
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Michiels
authors.forename: Perceval
authors.initials: P
authors.lastname: Sondag
authors.forename: Tara
authors.initials: T
authors.lastname: Scherder
authors.forename: Bruno
authors.initials: B
authors.lastname: Boulanger
mesh_terms: D001499:Bayes Theorem; D001702:Biopharmaceutics / Q000592:standards / Q000706:statistics & numerical data*; D002626:Chemistry, Pharmaceutical; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D015233:Models, Statistical; D011336:Probability; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*
keywords: Fit for purpose; Method validation; Quality by design; Tolerance intervals