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Related Experiment Video

Updated: Apr 21, 2026

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Analytical procedure validation and the quality by design paradigm.

Eric Rozet1, Pierre Lebrun, Jean-François Michiels

  • 1a Arlenda S.A. , Liège , Belgium.

Journal of Biopharmaceutical Statistics
|October 31, 2014
PubMed
Summary

Analytical procedure validation is integral to the quality by design (QbD) approach for pharmaceutical development. This validation ensures analytical methods are fit for purpose, establishing a design space for effective control strategies.

Keywords:
Fit for purposeMethod validationQuality by designTolerance intervals

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Regulatory Science

Background:

  • The ICH Q8 guideline promotes a Quality by Design (QbD) approach for pharmaceutical process development.
  • While QbD principles are applied to analytical procedure development and optimization, their integration into validation remains unclear.

Purpose of the Study:

  • To demonstrate that analytical procedure validation is a key component of the QbD paradigm.
  • To highlight the importance of validation in creating fit-for-purpose analytical procedures.

Main Methods:

  • Review of QbD principles and their application to analytical procedures.
  • Discussion of statistical methodologies, including Design of Experiments (DoE).
  • Exploration of statistical modeling and probabilistic statements in validation.

Main Results:

  • Analytical procedure validation is fully integrated within the QbD framework.
  • Validation ensures analytical procedures are fit for purpose.
  • Statistical tools are essential for robust validation.

Conclusions:

  • Analytical procedure validation within QbD leads to an analytical procedure design space.
  • The established design space enables the implementation of a control strategy.
  • This integrated approach enhances pharmaceutical development and product quality.