Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach

AAPS PharmSciTech

Volumn 5, Issue 1, 2004, Pages

  Bansal, Surendra K ^a   Layloff, Thomas ^b   Bush, Ernest D ^a   Hamilton, Marta ^c   Hankinson, Edward A ^d   Landy, John S ^e   Lowes, Stephen ^f   Nasr, Moheb M ^g   St Jean, Paul A ^h   Shah, Vinod P ^g  

^a HOFFMANN LA ROCHE INC   (United States)

^b Management Sciences for Health   (United States)

^c OSI PHARMACEUTICALS INC   (United States)

^d Pharm Div   (United Kingdom)

^e SANOFI   (France)

^f Advion BioSciences Inc   (United States)

^g CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^h WATERS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ANALYTIC METHOD; ANALYZER; ARTICLE; CALIBRATION; COMPUTER PROGRAM; COMPUTER SYSTEM; DATA ANALYSIS; DOCUMENTATION; DRUG MANUFACTURE; ENVIRONMENTAL FACTOR; EQUIPMENT DESIGN; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; INFORMATION SYSTEM; INSTRUMENTATION; NOMENCLATURE; PHARMACEUTICAL ENGINEERING; PROCESS CONTROL; QUALITY CONTROL; SPECTROMETER; SYSTEM ANALYSIS; VALIDATION PROCESS; APPARATUS, EQUIPMENT AND SUPPLIES; CHEMISTRY; CONFERENCE PAPER; DRUG INDUSTRY; METHODOLOGY; PHARMACEUTICS; STANDARD;

CHEMISTRY, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; EQUIPMENT AND SUPPLIES; TECHNOLOGY, PHARMACEUTICAL;

EID: 23144449770     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1007/bf02830588     Document Type: Article

References (11)

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3. International Conference on Harmonization. ICH Q2A: Text on Validation of Analytical Procedures. Federal Register. 1995;60 FR 11260. http://www.fda.gov/cder/guidance/ichq2a.pdf.
4. International Conference on Harmonization. ICH Q2B: Validation of Analytical Procedures: Methodology. Federal Register. 1997;62 FR 27463. http://www.fda.gov/cder/guidance /1320fnl.pdf.
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8. National Health and Welfare. Acceptable Methods. Drug Directorate Guidelines, National Health and Welfare, Health Protection Branch, Health and Welfare. Ottawa, Ontario, Canada. 1992.
9. US Food and Drug Administration. Guideline on General Principles of Process Validation. Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research. May 1987.
10. Furman WB, Layloff TP, Tetzlaff J. Validation of Computerized Liquid Chromatographic Systems. J AOAC. 1994;77:1314-1318.
11. US Food and Drug Administration. General Principles of Software Validation. Final Guidance for Industry and FDA Staff. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, January, 2002.