Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics

Abstract

These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regulatory documents sections with a detailed description of subsections structure, the peculiarities of presentation of the methods for evaluation of physicochemical quality characteristics of immunobiologicals and the typical mistakes made in the process of drafting regulatory documents.

Keywords

• иммунобиологические лекарственные препараты
• лабораторная экспертиза
• физико-химические показатели
• нормативная документация
• изложение методик
• immunobiological medicines
• laboratory testing
• physicochemical quality characteristics
• regulatory documentation
• presentation techniques