Validation of computerized systems in pharmaceutical analytical laboraties;Validierung computergestutzter Systeme in pharmazeutisch-analytischen Labors

Pharmazeutische Industrie

Volumn 58, Issue 10, 1996, Pages 935-940

  Huber, Ludwig ^a,b  

^a Hewlett Packard GmbH   (Germany)

^b Worldwide HPLC Products   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPUTER SYSTEM; DOCUMENTATION; DRUG ANALYSIS; LABORATORY; PHARMACEUTICS;

EID: 0029802541     PISSN: 0031711X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. OECD, The Application of the principles of GLP to computerized systems, Series on principles of good laboratory practice and compliance monitoring, GLP consensus document number 10, Environmental monograph 116, Organization for Economic Cooperation and Development (OECD), Paris (1995)
2. EU, EG-Leitfaden einer Guten Herstellungspraxis für Arzneimittel, G. Auterhoff (Hrsg.), 4. Aufl., ECV Editio Cantor Verlag, Aulendorf (1995)
3. EC CPMP, Good clinical practice for trials on medicinal products in the European Community, S. 23, Commission of the European Communities, Brussels, (1991)
4. US FDA, General principles of Validation, Center for Drug Evaluation and Research (CDER), Rockville, MD (1987)
5. DIN EN 8402, Qualitätsmanagement - Begriffe (ISO 8402: 1994), Beuth Verlag, Berlin (1994)
6. PMA's Computer System Validation Committee, Validation concepts for computer systems used in the manufacture of drug products, Pharm. Technol. 10, 24 (1986)
7. Huber, L., Gute Labor-Praxis, Publ. Nr. 12-5091-6259G, Hewlett-Packard, Waldbronn (1993)
8. Huber, L., Validierung computergesteuerter Analysensysteme, Springer-Verlag, Berlin (1996)
9. Furman, W. B., Layloff, T. P., Tetzlaff, R. F., Validation of computerized liquid chromatographic systems, J. AOAC Intern. 77, 1314 (1994)
10. OECD, Compliance of laboratory suppliers with GLP principles, Series on principles of good laboratory practice and compliance monitoring, number 5, GLP consensus document, environment monograph No. 49, OECD, Paris (1992)
11. Tetzlaff, R. F., GMP documentation requirements for automated systems, part III, FDA inspections of computerized laboratory systems, Pharm. Tech., S. 71/82 (1992)
12. Huber, L., Thomas, M., Validating computer controlled analytical systems in the pharmaceutical laboratory, LC/GC Magazine, 466/473 Juni 1995
13. Eurachem, D., Akkreditierung für chemische Laboratorien: Richtlinien zur Interpretation der Normen-Serie 45000 und ISO Guide 25 (deutsche Übersetzung), Juni 1993, Gesellschaft Deutscher Chemiker, Frankfurt/Main (1993)