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Plans for implementation of a quality system in the control laboratory of the Romanian National Medicines Agency
Authors:I-L Popescu  H Y Aboul-Enein  D V Napradean  G L Radu  I G Tanase
Institution:(1) National Medicines Agency, Control Department, 48 Av. Sanatescu Street, Bucharest 1, Romania, RO;(2) Pharmaceutical Analysis Laboratory, Biological and Medical Research Department, MBC-03, King Faisal Specialist Hospital and Research Centre, Riyadh 11211, Saudi Arabia e-mail: enein@kfshrc.edu.sa Fax: +9661-442-7858, SA;(3) National Institute for Biological Sciences, Department of Analytical Biochemistry, 269, Spl. Independentei, P.O. Box 17–16, 77748 Bucharest, Romania, RO;(4) University of Bucharest, Faculty of Chemistry, Department of Analytical Chemistry, 4–12 Blvd. Elisabeta, 703401 Bucharest 3, Romania, RO
Abstract:This paper describes the practical implementation of a quality system in the control laboratory of the National Medicines Agency, Romania, the main aim being the alignment of the requirements of the control of drugs in Romania with European Union standards. Activity in this field is relatively new in Romania, however, it is of great importance to Romania’s compliance with international standards. Received: 13 September 2000 Accepted: 19 February 2001
Keywords:  Standards  Quality system  Drug control laboratory
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