Purity of Medicinal Products
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Purity of Medicinal Products Birgit Sólvkær Jensen, Lisbeth Ehlert Knudsen and Poul Vibholm Petersen Drug Information Journal 2000 34: 895 DOI: 10.1177/009286150003400325 The online version of this article can be found at: http://dij.sagepub.com/content/34/3/895
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Drug Informarion J o v m l . Vol. 34, pp. 895-902, 2000
0092-86 15/2000 Copyright Q 2000 Drug Informalion Association Inc.
Printed in the USA. All rights reserved.
PURITY OF MEDICINAL PRODUCTS BIRGITSPILVKKR JENSEN, MSC PHARM Laboratory for Quality Evaluation and Control
LISBETHEHLERT KNUDSEN,PHD Toxicologist, Medical Department
POULVIBHOLM PETERSEN, MSc PHARM Laboratory for Quality Evaluation and Control The Danish Medicines Agency, Branshcij, Denmark
This paper provides some general views on the current guidelines on the purity of medicinal products, with the purpose of informing the medicinal industry about the Danish Medicines Agency’s view on how to establish requirements on impurities in chemicallysynthesised active substances (the Danish Medicine Agency’s rules of thumb do not cover nonchemical substances) and medicinal products for human use. It should be emphasized that the points of views represent the Danish Medicines Agency’s interpretation of the quality guidelines in question. Key Words: Danish Medicines Agency; Purity; Medicinal products
INTRODUCTION
of the medicinal product. Analytical methods are tested and the approved specifications WHEN A MEDICINAL company applies checked. The Medical Department at the for a marketing authorization for a new meagency handles pharmacovigilance matters dicinal product comprehensive documentaand receives information from the internation according to the “Notice to Applicants” tional “rapid alert system” to react quickly (1) is requested on the quality, safety, and in cases of serious side effects, for example, efficacy of the medicinal product. The Danif a pharmacologically very potent or toxic ish Medicines Agency assesses this registraimpurity is suddenly reported. Close coopertion file (dossier) before the eventual grantation between the Medical Department and ing of a marketing authorization. the Laboratory for Quality Evaluation and Postapproval, the Danish Laboratory for Control ensures a uniform interpretation of Quality Evaluation and Control controls the the relevant guidelines. quality of the medicinal product on an ongoVery important parts of the dossier coning basis through assessment of applications cern the purity
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