The particle size distribution of particulate systems in the sub-micron and micron range can be measured using the principle of laser diffraction. Samples are tested as either wet or dry dispersions. The exact methodology used to test a sample is specific to both the sample type and instrument setup. Phase-appropriate method development must be performed to ensure subsequently generated data is accurate and reliable, and this method development should follow a systematic approach. One such approach being adopted in GMP (Good Manufacturing Practice) environments is ‘Quality by Design (QBD) for Analytical Methods’ as described in 2018’s ICH Q14: ‘’Analytical Procedure Development’’. The QBD for Analytical Methods approach encourages the pre-definition of objectives for method development in the form of an ‘Analytical Target Profile’ (i.e. the performance requirements of the method which must be met) and associated ‘Critical Method Attributes (CMAs)’ (i.e. those analytical parameters and conditions which significantly impact method performance).
This study highlights how QBD for Analytical Methods is not only limited to method development, as it can also be used to support method transfer between different generations of particle size analyzer.
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The particle size distribution of particulate systems in the sub-micron and micron range can be measured using the principle of laser diffraction. Samples are tested as either wet or dry dispersions. The exact methodology used to test a sample is specific to both the sample type and instrument setup. Phase-appropriate method development must be performed to ensure subsequently generated data is accurate and reliable, and this method development should follow a systematic approach. One such approach being adopted in GMP (Good Manufacturing Practice) environments is ‘Quality by Design (QBD) for Analytical Methods’ as described in 2018’s ICH Q14: ‘’Analytical Procedure Development’’. The QBD for Analytical Methods approach encourages the pre-definition of objectives for method development in the form of an ‘Analytical Target Profile’ (i.e. the performance requirements of the method which must be met) and associated ‘Critical Method Attributes (CMAs)’ (i.e. those analytical parameters and conditions which significantly impact method performance).
This study highlights how QBD for Analytical Methods is not only limited to method development, as it can also be used to support method transfer between different generations of particle size analyzer.
