A new whitepaper on the application of Analytical Quality by Design (AQbD) to particle size assessment has been published by Malvern Panalytical.
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 Panalytical’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 Panalytical resource center.
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 Panalytical 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.
Malvern Panalytical, Malvern Panalytical, Zetasizer and Mastersizer are registered trademarks of Malvern Panalytical
About Malvern Panalytical
Malvern Panalytical provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern Panalytical’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.
Our products reflect Malvern Panalytical’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.
Malvern Panalytical systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.
Headquartered in Malvern Panalytical, UK, Malvern Panalytical has subsidiary organizations in all major European markets, North America, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com