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Experts’ attention is focused on harmonization

30 April 2015

International Forum and Exhibition in the field of pharmaceuticals and biotechnology IPhEB&CPhI Russia 2015 was held in Moscow on April 27.

This year the event was held in Moscow for the first time, the forum and the exhibition attracted a lot of people. More than 3 thousand visitors from 40 countries attended the event. Intensive business program allowed experts from different countries to discuss the most important issues in terms of regulatory practice, development of international partnerships and further growth of local pharmaceutical industry.

Harmonization was the main topic of this year’s Forum. It was discussed in different aspects. One of the main subjects was the harmonization of medications circulation in the Eurasian Economic Union. Experts also discussed aspects of harmonization of regulations and requirements for pharmaceutical production, laboratory testing and clinical trials as well as the international cooperation in the context of innovative development of the industry.

Natalia Novichkova, Quality Director of GEROPHARM, Group of Companies, contributed to the session on harmonization of regulations and requirements for pharmaceutical production in the Eurasian Economic Union. In her speech she shared a real experience of the company in terms of development of pharmaceutical quality assurance system and told about main steps in development and maintenance of GMP standards at the factory of GEROPHARM-Bio located in Obolensk (the Moscow region).

Natalia Novichkova also noted that advantages of drugs produced by aseptic filling could not be dissociated from risks appearing during their use. Absence of solid particles and sterility of drugs injected directly into the patient’s bloodstream are the main priorities. Qualification and validation of processes are critically important for the maintenance of standards in this field.

Outsourcing causes a number of difficulties and problems associated with a significant volume of validation work and number of sites, high costs and complicated operational management within the schedule time frame. Besides, outsourcing providers often lack some necessary testing equipment.

Telling about the company’s case on addressing such issues, Natalia Novichkova explained that GEROPHARM decided to create its own validation equipment stock. This gave the company certain advantages, such as: Possibility to carry out any tests and trials at any time in order to confirm quality of processes. It also helped to substantially reduce costs for such works in comparison with outsourcing. In 2013-2014 the company developed a validation master plan and testing methodology. Documentation was revised correspondingly and trainings for staff members were performed. Thus, quality became not only the foundation for the whole production, but a philosophy of each employee.

Reference:

Today the factory of GEROPHARM-Bio is the only manufacturing plant where genetically engineered human insulin is produced using full cycle principle, from substance to finished dosage form. In 2014 the company received the Certificate of Conformance to Good Manufacturing Practice (GMP) production requirements from Ukraine authorities (PIC/S GMP). In spring 2015 GEROPHARM-Bio received Russian GMP certificate: The conclusions were issued for compliance of production organisation and quality control of drug products and pharmaceutical substances.

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