STEFAN TYSKI, JOLANTA ZAJDEL-DĄBROWSKA

HARMONIZACJA MONOGRAFII FARMAKOPEALNYCH DOTYCZĄCYCH BADANIA MIKROBIOLOGICZNEGO PRODUKTÓW NIEJAŁOWYCH I ICH KATEGORYZACJI.
2008-08-16

Harmonization of pharmacopoeial monographies concerning microbiological examination of non-sterile products. Harmonisation among the world's three major pharmacopoeias, the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopoeia, is currently an important and challenging task, as these standards present important tool in the registration, market surveillance, and exchanging as well trading medicines across as many countries as possible. Recently, 3 main general chapters connected with microbiological evaluation of non-sterile preparations (2.6.12, 2.6.13 and 5.1.4) have been harmonized.