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PHARMACOPOEIA - SET OF QUALITY REQUIREMENTS FOR MEDICINAL PRODUCTS

Ewa Leciejewicz-Ziemecka 

Urzad Rejestracji PLWMiPB, Zabkowska 41, Warszawa 03-736, Poland

Abstract

Correct quality of medicinal products is connected with full filing all the criteria of quality of: identification, purity, content of active substance and functionality which are included in suitable documents, e.g. in pharmacopoeial monographs. General and individual monographs compose the Pharmacopoeia, however the national and international legislation makes them obligatory standards at a given territory.

Current requirements of European Pharmacopoeia (Ph. Eur.) are contained in its 5th edition with Supplements 5.1, 5.2 and 5.3., and of Polish Pharmacopoeia - in its 6th edition (Ph. Pol. VI). The published in 2005, "Supplement 2005" of the 6th edition of Polish Pharmacopoeia is a link between European and Polish Pharmacopoeias. It contains Polish versions of Ph.Eur. monograph titles as well as Ph.Eur. monographs of water for pharmaceutical use. The Polish version of European Pharmacopoeia is currently prepared in the Office for Registration.
 

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Related papers

Presentation: Oral at V Multidyscyplinarna Konferencja Nauki o Leku, by Ewa Leciejewicz-Ziemecka
See On-line Journal of V Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2006-02-14 10:08
Revised:   2009-06-07 00:44