Standardization

Standardization of pharmaceuticals of natural origin is complicated by variability and insufficient knowledge about chemical composition of raw materials, variety of BAS (biologically active substances), the lack of reference compounds and other factors, especially in case of the complex pharmaceuticals. To investigate the composition of BAS and to develop methods of standardization we use a wide range of techniques, e. g. chromatographic, spectrophotometric and others.

In view of a range of BAS and specifics of dosage form methods of standardization of finished dosage form are developed.

The data obtained are used to create project specifications for subsequent inclusion in the developed standard documentation (manufacturer monograph, manufacturing instructions). Furthermore, analysis of safety of the drug at the stage of preclinical tests may contribute to a change in the composition of dosage form and regulatory documentation.

Work performed:

• Planning and organization of standardization process of production and services;
• Analysis of legislative level on standardization and certification of professional qualifications;
• Participation in developmental and experimental studies;
• Development of methods of analysis and assessment criteria;
• Development of standard documentation (manufacturer monograph, TC (technical conditions), ND (normative documents), etc.) and revision of current normative documents;
• Improvement of quality and competitiveness of production and services by standardization methods;
• Performing an obligatory normalizing control of technical documentation;
• Preparation of documents for registration and representation in branch agency of scientific and technical information;
• Participation in conferences, seminars, symposiums on actual problems of technical regulation, standardization, compliance assessment;
• Analysis of russian and foreign experience on standardization and certification;
• Timely and high-quality performance of goals and tasks.