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Risk-based approach for method development in pharmaceutical quality control context: A critical review.

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Summary

Analytical Quality by Design (AQbD) offers a systematic, risk-based approach to pharmaceutical quality control method development. This methodology ensures analytical method performance throughout its lifecycle, enhancing drug manufacturing quality.

Keywords:
Analytical quality by designDesign of experimentsDrug analysisMethod operable design regionQuality controlRisk based approach

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Quality Control

Background:

  • Regulatory bodies mandate systematic approaches in pharmaceutical product development.
  • Quality control methods are crucial for ensuring drug manufacturing quality.
  • A risk-based approach is recommended for analytical method development to ensure fitness for purpose throughout the method's lifecycle.

Purpose of the Study:

  • To discuss the Analytical Quality by Design (AQbD) workflow and its application in developing pharmaceutical quality control methods.
  • To review recent publications on AQbD applications in separation techniques.
  • To provide an overview of different AQbD development strategies, including their advantages and disadvantages.

Main Methods:

  • The paper discusses the AQbD workflow, a risk management-oriented methodology.
  • It reviews literature on AQbD implementation in analytical method development, particularly for separation techniques.
  • Different AQbD development strategies are presented and analyzed.

Main Results:

  • AQbD enables quality to be designed into analytical processes through a deep understanding of procedures.
  • The review highlights successful applications of AQbD in pharmaceutical quality control.
  • Various development strategies are showcased, detailing their respective pros and cons.

Conclusions:

  • AQbD is a valuable methodology for developing robust and reliable analytical methods in pharmaceutical quality control.
  • Implementing AQbD ensures that analytical methods meet their intended purpose throughout their lifecycle.
  • This systematic approach supports compliance with increasing regulatory expectations for pharmaceutical product development.