NovaMedica spoke on its experience in improving quality systems of pharmaceutical enterprises at the 9th All-Russian GMP Conference

The 9^th All-Russian GMP Conference was held in Ufa on August 21-23. It was named as the biggest event of the pharmaceutical industry in the field of developing good manufacturing practices. NovaMedica experts shared their experience in managing data integrity, which was highly appreciated by the participants for its relevance and practical value.

The 9th All-Russian GMP Conference, supported by the Ministry of Industry and Trade of the Russian Federation and the State Institute of Drugs and Good Practices, brought together more than 350 experts on quality management systems and good manufacturing practices, representatives of government bodies, professional associations and communities, managers and specialists of pharmaceutical production facilities from 25 countries.

The business program of the Conference in 2024 included issues of development and improvement of the regulatory system in the pharmaceutical industry, expansion of domestic production, in particular of innovative drugs, to ensure drug safety of the country.

The participants discussed the prospects for drug manufacturers in the market of the EAEU member states, the specifics of entering the markets of other countries from the regulator’s and the manufacturer’s point of view, and the value of convergence of different countries’ regulatory requirements for the development of export potential.

Specialists were particularly engaged by interactive sections for exchanging experience of domestic and foreign drug manufacturers in the field of practical implementation and maintaining of corporate culture of quality, and ensuring data integrity.

The unique format of the interactive educational workshop The Current Aspects of Internal GMP Audit at Pharmaceutical Enterprises organized by the Eurasian Academy of Good Practices brought together an audience of more than 170 specialists. It should be noted that the event was held with the help of the latest education technologies, including artificial intelligence.

It was in this interactive format that the Director for Quality of NovaMedica LLC Ekaterina RASTOLTSEVA presented her report on Data Integrity Management for Laboratory Equipment to the participants. The topic is of significant importance for the industry, since compliance with data integrity requirements at a pharmaceutical enterprise directly affects the quality and safety of drugs. When inspecting pharmaceutical production facilities, the regulator pays great attention to compliance with the EAEU Guidelines on Data Integrity.

Conformity to the EAEU requirements can be checked at the enterprise on a routine basis as part of the self-inspection procedure. The report by Ekaterina RASTOLTSEVA examined the most common data integrity non-conformities in quality control laboratories, and proposed ways to solve typical problems and develop efficient corrective and preventive actions.

Attendees of the Conference pointed out the relevance of the business program and the high level of participants of the educational workshop organized by the Eurasian Academy of Good Practices.

“I would like to thank the organizers for the high assessment of NovaMedica’s experience and the opportunity to present the results of our work in the field of quality to the colleagues. The format of the session allowed us to engage the audience in an active dialogue with experts, to ask questions and discuss important GMP compliance issues. The use of artificial intelligence in education is a promising direction for development and a step towards increasing the effectiveness of education programs,” Ekaterina RASTOLTSEVA commented on the results of participation in the 9^th All-Russian GMP Conference.