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Related Concept Videos

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Related Experiment Video

Updated: Nov 9, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Analytical Method Lifecycle Management in Pharmaceutical Industry: a Review.

Lúcia Volta E Sousa1, Ricardo Gonçalves2, José C Menezes3

  • 1Analytical Development, R&D, Hovione FarmaCiência S.A, Campus do Lumiar, Edifício R, Estrada do Paço do Lumiar, 1649-038, Lisboa, Portugal. lvsousa@hovione.com.

AAPS Pharmscitech
|April 9, 2021
PubMed
Summary
This summary is machine-generated.

Quality by Design (QbD) and Analytical Method Lifecycle Management (AMLM) ensure pharmaceutical product quality through risk management and continuous improvement. This integrated approach enhances method reliability and reduces failures.

Keywords:
Analytical Lifecycle Management (AMLM)Analytical Quality by Design (AQbD)ICH Q12ICH Q14ICH Q2

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Quality Management

Background:

  • Quality by Design (QbD) and Analytical Method Lifecycle Management (AMLM) are increasingly adopted in the pharmaceutical industry.
  • These concepts leverage scientific knowledge and quality risk management for continuous improvement and reliable analytical results.

Purpose of the Study:

  • To describe the integrated application of QbD and AMLM for pharmaceutical product quality assurance.
  • To highlight the alignment of analytical method variability with product requirements.

Main Methods:

  • The Analytical Method Lifecycle Management (AMLM) framework, encompassing Method Design (using QbD), Method Performance Qualification, and Continued Method Performance Verification.
  • Application of knowledge and risk management principles throughout the method lifecycle.

Main Results:

  • Holistic alignment of method variability with product requirements, leading to increased confidence in generated data.
  • Enhanced method robustness, cost reduction, and decreased risk of failures.
  • Regulatory acknowledgment and industry acceptance of the QbD and AMLM approach.

Conclusions:

  • The integrated QbD and AMLM approach provides a robust framework for ensuring pharmaceutical quality and regulatory compliance.
  • This lifecycle management enhances analytical data reliability, operational efficiency, and risk mitigation.