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Qualification validation and calibration

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Qualification, Validation and Calibration Samarwadee Plianwong, Ph.D. Faculty of Pharmaceutical Sciences, Burapha University Objectives After this class, the students should; • Understand and explain concepts of qualification, validation and calibration • Understand the validation documents and validation master plan • Understand and explain the qualification stages • Understand and explain V-model in pharmaceutical manufacturing • Understand and explain the types of validation • Understand and explain the importance of equipment calibration Qualification (การตรวจร ับรอง) Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. ่ นยันว่า เครืองมื ่ อ หรือระบบเสริม การพิสจู น์และจัดทาเอกสารเพือยื ้ างเหมาะสม มีการทางานอย่างถูกต ้อง และได ้ผลตามที่ ต่าง ๆ มีการติดตังอย่ คาดหวัง การตรวจรบั รองเป็ นส่วนหนึ่ งของการตรวจสอบความถูกต ้อง แต่การ ้ ...
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