Scientific aspects of the development of the State Pharmacopoeia of Ukraine
Abstract
The development of the State Pharmacopoeia of Ukraine (SPU) is based on the following principles: harmonization with the European Pharmacopoeia (EP); consideration of national specificity, self-sufficiency, National System of Pharmacopoeial Reference Standards (PhRS), feedback from users. For implementing the mentioned principles 4 main scientific areas of activity have been developed: proper elaboration of SPU texts, the National System of the PhRS, Proficiency Testing Scheme for medicines control laboratories (PTS), metrological support (in particular the validation of analytical procedures). The specificity of developing texts for SPU 1 (2001) and 2 editions (2016) have been analyzed for the following sections: general chapters, monographs for pharmaceutical substances, finished drug products, herbal medicinal products, compounded preparations, etc. The concept of further development of SPU has also been discussed.
Keywords
Государственная фармакопея Украины,
лекарственные средства,
фармакопейные стандартные образцы,
Программы профессионального тестирования лабораторий,
метрологическое обеспечение,
общие и частные фармакопейные статьи,
State Pharmacopoeia of Ukraine,
medicines,
pharmacopoeial reference standards,
Professional Testing Schemes,
metrological support,
general chapters and specific monographs
About the Author
A. I. Gryzodub
Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines
Russian Federation
Russian Federation
References
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Review
For citations:
Gryzodub A.I. Scientific aspects of the development of the State Pharmacopoeia of Ukraine. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(2):19-25. (In Russ.)
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