Quality assessment of medicinal substances and products
Quality assessment of medicinal substances and products is based on the polish-language monograph Ocena jakości substancji i produktów leczniczych, edited by M. Zając and A. Jelińska, published by Wydawnictwo Naukowe Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, 2010 (The Science Publishing House of Poznan University of Medical Sciences, 2010).
In the present monograph, the analytical methods for medicinal substances were adjusted to Ph. Eur.
7.0/Pharmacopoeia Polonica IX whereas those for medicinal products to BP 2011 and USP 35.
Since substances for pharmaceutical use and pharmaceuticals available on the market have to be of
appropriate quality ensuring safety and use efficacy, they should meet all criteria regarding their identity, purity, content and usefulness that are contained in relevant documents, including pharmacopoeial monographs. In Poland, the obligatory document is currently Pharmacopoeia Polonica IX, a Polish translation of European Pharmacopoeia 7.
7.0/Pharmacopoeia Polonica IX whereas those for medicinal products to BP 2011 and USP 35.
Since substances for pharmaceutical use and pharmaceuticals available on the market have to be of
appropriate quality ensuring safety and use efficacy, they should meet all criteria regarding their identity, purity, content and usefulness that are contained in relevant documents, including pharmacopoeial monographs. In Poland, the obligatory document is currently Pharmacopoeia Polonica IX, a Polish translation of European Pharmacopoeia 7.