E. Leciejewicz-Ziemecka, J. Pachecka

Farmakopea Polska - od wymagań narodowych do zharmonizowanych

The Polish Pharmacopoeia - from national to harmonized requirements
Correct quality of medicinal products is connected with full - ling all the criteria of quality of: identi cation, 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.Pharmacopoeias are published as sequential editions, volumes or supplements. Since January 2008 the 6th edition of the European Pharmacopoeia has been obligatory. The requirements of the European Pharmacopoeia are introduced into VII/VIII edition of the Polish Pharmacopoeia.Pharmacopoeial harmonization process is connected with an activity of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals, whose guidances facilitate the registration of medicinal product in the di erent countries of the world.
Keywords: European Pharmacopoeia, Polish Pharmacopoeia, pharmacopoeial harmonization.

Farmakopea Polska - od wymagań narodowych do zharmonizowanych

102.16 kB | 21 grudnia 2017