Quality Management and Calibration

Abstract

Good specification of a product’s performance requires adequate characterization of relevant properties. Particulate products are usually characterized by some PSD, shape or porosity parameter(s). For proper characterization, adequate sampling, dispersion, and measurement procedures should be available or developed and skilful personnel should use appropriate, well-calibrated/qualified equipment. The characterization should be executed, in agreement with customers, in a wellorganized laboratory. All related aspects should be laid down in a quality handbook. The laboratory should provide proof for its capability to perform the characterization of stated products and/or reference materials within stated confidence limits. This can be done either by internal validation and audits or by external GLP accreditation.