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A practical approach to method validation in pharmaceutical analysis.

G P Carr1, J C Wahlich

  • 1Medgenix Group, Fleurus, Belgium, UK.

Journal of Pharmaceutical and Biomedical Analysis
|January 1, 1990
PubMed
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Regulatory guidelines require analytical method validation for registration dossiers. This paper offers practical approaches for conducting validation, focusing on accuracy, linearity, and detection/quantitation limits.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Regulatory Affairs

Background:

  • Regulatory Authorities mandate analytical method validation for drug registration dossiers.
  • Existing guidelines lack specific instructions on validation procedures and expected outcomes.
  • There is a need for practical guidance on conducting method validation.

Purpose of the Study:

  • To provide practical approaches for conducting analytical method validation.
  • To offer guidance on determining key validation parameters: accuracy, linearity, and limits of detection/quantitation.
  • To address the ambiguity in current regulatory guidelines regarding method validation.

Main Methods:

  • The study reviews current regulatory guidelines on analytical method validation.

Related Experiment Videos

  • It proposes practical methodologies for assessing accuracy and linearity.
  • It discusses approaches for determining the limit of detection (LOD) and limit of quantitation (LOQ).

    • Main Results:

    • The paper suggests a framework for performing method validation in alignment with regulatory expectations.
    • It provides clear methodologies for evaluating accuracy and linearity, crucial for dossier submissions.
    • It outlines practical strategies for establishing reliable LOD and LOQ values.

    Conclusions:

    • Implementing the proposed practical approaches can enhance the quality and consistency of analytical method validation.
    • This guidance aids researchers and regulatory professionals in meeting validation requirements for registration dossiers.
    • The study contributes to standardizing validation practices in pharmaceutical analysis.