Method Development and Validation for Particle Size and ...

Method Development and Validation for Particle size and Shape Measurements Ulf Will n Divisional Product Manager Analytical Imaging Systems Malvern Instruments Ltd, Malvern, UK. FDA guidance: when should Particle size be measured? International Conference on Harmonization;. Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances*. New Drug Substances (b) Particle size : For some new drug substances intended for use in solid or suspension drug products, Particle size can have a significant effect on dissolution rates, bioavailability, and/or stability. In such instances, testing for Particle size distribution should be carried out using an appropriate procedure, and acceptance criteria should be provided. Decision Tree #3 provides additional guidance on when Particle size testing should be considered.

“The normal concepts of validation may differ for particle size methodologies as compared to other analytical methodologies such as HPLC.” “… the system should be calibrated according to the

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