Consistency of FMEA used in the validation of analytical procedures

Journal of Pharmaceutical and Biomedical Analysis

Volumn 54, Issue 3, 2011, Pages 592-595

  Oldenhof, M T ^a   van Leeuwen, J F ^a,b   Nauta, M J ^a,c   de Kaste, D ^a   Odekerken Rombouts, Y M C F ^a   Vredenbregt, M J ^a   Weda, M ^a   Barends, D M ^a  

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

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c TECHNICAL UNIVERSITY OF DENMARK   (Denmark)

Author keywords

Analytical validation; FMEA; Reproducibility; Risk analysis

Indexed keywords

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DRUG QUALITY; FAILURE MODE AND EFFECTS ANALYSIS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PRIORITY JOURNAL; PROBABILITY; QUALITY CONTROL; RELIABILITY; RISK ASSESSMENT; VALIDATION PROCESS;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CLINICAL LABORATORY TECHNIQUES; EQUIPMENT FAILURE ANALYSIS; MASS SPECTROMETRY; PHARMACEUTICAL PREPARATIONS; PROBABILITY; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; RISK MANAGEMENT; SENSITIVITY AND SPECIFICITY; VALIDATION STUDIES AS TOPIC;

EID: 78149500279     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.09.024     Document Type: Article

References (8)

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