Application Note
Method Validation For Laser Diffraction Measurements
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•Application Note: Method Validation For Laser Diffraction Measurements
When undertaking particle size measurements it is important to validate the analysis method to ascertain both its robustness and integrity. This allows the key variables associated with variability in the results to be determined and then controlled as part of the measurement procedure. The implementation of a validation study is an absolute requirement in the pharmaceutical industry and of growing significance throughout the manufacturing sector where the need for result consistency is important to ensure efficient production and quality control.
Validation is described by the US Food and Drug Administration (FDA) as "establishing documentary evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes" [1]. The FDA Guidance to Industry document goes on to state that for particle sizing methods (including laser diffraction) that the intermediate precision and robustness of the method should be studied.
Users of laser diffraction instruments for particle characterization applications have a wealth of information on the theory behind the technology as well as guidance on both sampling and dispersion [2,3,4]. In 1999 the Pharmaceutical Analytical Sciences Group (PASG) [5] laid down some guidelines as to the process which should then be followed during method validation. The work of the PASG group is built upon here with practical examples of how validation can be carried out. Lerke and Adams [6] have also published their ideas on the subject in a useful paper. Their paper covers both method development and method validation, whereas this note is mainly concerned with the latter.
Note that following the procedures outlined here cannot guarantee that an auditing body will always approve a given method. Rather the minimum amount of work expected to be performed is outlined. Any additional studies will only strengthen the case for the candidate method.
SOURCE: Malvern Instruments
Click Here To Download:
•Application Note: Method Validation For Laser Diffraction Measurements
