Requirements for excipients and package as drug manufacturing quality assurance

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DOI: https://doi.org/10.29296/25419218-2019-05-02
Issue: 
5
Year: 
2019

A.E. Durnovtseva(1), A.V. Foteeva(1), T.V. Bombella(1), N.B. Rostova(2) 1-OOO «Parma Clinical», 34, Maksim Gorky St., Perm 614000, Russian Federation 2-Perm State Pharmaceutical Academy, 2, Polevaya St., Perm 614990, Russian Federation

The main task of Russian drug manufacturers is to bring safe and effective drugs to the market. There are parameters that affect the quality of drugs; in particular these are the used active ingredients and excipients and applied packaging/corking system. The regulatory system in the Russian Federation has not contributed to the monitoring of the quality indicators of excipients and primary packaging materials for a long time. Harmonization of the national registration procedure and transition to the international requirements of the Eurasian Economic Community (ErrAsEC) have now resulted in a great change in the approach to assessing the quality indicators for expedients and the packaging/corking system from the point of view of the regulatory system. These positive changes contribute to the circulation of the most effective and safe proper-quality drugs on the market of the Russian Federation.
Keywords: 
regulatory requirements
excipients
quality control of excipients
primary packaging material
quality control of packaging materials
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