Risk analysis of analytical validations by probabilistic modification of FMEA

Journal of Pharmaceutical and Biomedical Analysis

Volumn 64-65, Issue , 2012, Pages 82-86

  Barends, D M ^a   Oldenhof, M T ^a   Vredenbregt, M J ^a   Nauta, M J ^b  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^b TECHNICAL UNIVERSITY OF DENMARK   (Denmark)

Author keywords

Analytical validation; FMEA; Human factor; NIR; Risk analysis

Indexed keywords

COUNTERFEIT DRUG;

ARTICLE; CHEMICAL ANALYSIS; PRIORITY JOURNAL; PROBABILITY; RISK ASSESSMENT; SCORING SYSTEM; TABLET; VALIDATION PROCESS;

CHEMISTRY TECHNIQUES, ANALYTICAL; COUNTERFEIT DRUGS; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SPECTROSCOPY, NEAR-INFRARED; TABLETS;

EID: 84859268321     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.02.009     Document Type: Article

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