fulltext_016 - Chapter 17 Quality Management and...

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403 Abstract±: Good specification of a product’s performance requires adequate char- acterization 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 well- organized 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. ±17.1± ±Introduction± The quality aspects of particle characterization are or should be directly related to product performance, as already discussed in Chap. 3. In the same chapter, various candidate parameters for characterization are discussed. Of course, both method and technique used should allow adequate characterization. Thus, size measurement ±Chapter±±17± Quality Management and Calibration H.G. Merkus, Particle Size Measurements, DOI 10.1007/978-1-4020-9015-8_17, © Springer Science+Business Media B.V. 2009 Good practice requires: standard operating procedures and protocols adequate education and skills of operators quantitative statements on required measurement quality procedure for instrument qualification / method validation instructions for dealing with out-of-specification qualification results instructions for instrument maintenance documentation of all results and interventions Contents 17.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403 17.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404 17.3 Qualification and Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405 17.4 Quality Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 407 17.5 Laboratory Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 17.6 Practical Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 17.7 Definitions, Abbreviations and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 409 Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 410
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404 17 Quality Management and Calibration range, precision, bias, resolution, sensitivity, and lower determination limit should be fit for purpose. Usually, requirements for size range and precision are dominant.
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