A new whitepaper on the application of Analytical Quality by Design (AQbD) to particle size assessment has been published by Malvern Instruments. AQbD is an innovative approach to the development and validation of analytical methods that brings the benefits of Quality by Design (QbD) to pharmaceutical analysis. Malvern’s new whitepaper, ‘Beyond SOPs – Exploring the rigor and requirements of Analytical QbD’, introduces the AQbD concept, explains the associated workflow and illustrates how to apply AQbD when developing methods for laser diffraction particle sizing. The whitepaper is freely available for download from the Malvern resource center http://www.malvern.com/beyond_sops.
QbD strategies are now firmly entrenched throughout pharmaceutical development and manufacture, and the benefits of their broader application are being recognized. AQbD is the application of QbD to analytical method development, which involves systematically identifying the risks associated with the variables that may impact analysis. It calls for a more detailed understanding of the analytical method and the factors that can influence it, to establish a design space which offers the reward of robust analytical methods that improve throughout the lifecycle of pharmaceutical product.
The whitepaper introduces the regulatory benefits of applying AQbD approach to method development and highlights the parallels between AQbD and the more established QbD workflow. It goes on to present experimental results showing how to scope the method operable design region (MODR). This is the range of operating parameters that ensures accurate analysis, for both wet and dry laser diffraction particle size analysis. It also covers method validation and the need to implement a carefully constructed control strategy to ensure consistently robust and precise analysis.
Malvern Instruments played a leading role in the introduction of SOP-driven particle size analysis more than a decade ago and delivers the know-how, technology and instrumentation to support continuing innovation in pharmaceutical analysis. ‘Beyond SOPs – Exploring the rigor and requirements of Analytical QbD’ concludes with a review of the tools and software features of the Mastersizer 3000 that can help with the implementation of AQbD to particle size measurement.
To download the whitepaper go to: http://www.malvern.com/beyond_sops.
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