The first day of the exhibition "Analitika Expo 2025" has come to an end. Visitors were able to get acquainted with a wide range of laboratory equipment and chemical reagents from Russian and foreign participants, as well as attend the events of the scientific and business program.

Results of events in the Lecture Hall

Plenary session "Work of the analytical laboratory. Overcoming challenges and improving results"

The event partner is the Roskhimreaktiv Association. The session was moderated by Irina Vendilo, CEO of the Roskhimreaktiv Association.

Artur Vladimirovich Smirnov , Director of the Department of Chemical Industry of the Ministry of Industry and Trade of the Russian Federation, delivered a report on "Development of the chemical industry in Russia. Work of analytical laboratories in the context of National Projects" . The chemical complex of the Russian Federation occupies 11% in manufacturing industries, more than 650 thousand people are employed in the industry. In 2024, 19 investment projects worth 46.7 billion rubles were launched. The national project "New Materials and Chemistry" is aimed at achieving technological independence and includes 6 federal projects. The national project provides for the implementation of 55 technological chains. Speaking about personnel policy, Artur Smirnov noted that within the framework of the corresponding federal project, it is planned to reduce the personnel deficit by 2030, which is currently estimated at 100 thousand specialists. The new project in 2025 will be the national project "Bioeconomics".

At the end of his speech, the speaker spoke about government support measures, including: grants for the development of design documentation, subsidies for R&D in modern technologies, grants to support technological developments, and others.

"Technical Regulation "On the Safety of Chemical Products". Near-Term Prospects" was the topic of the speech by Georgy Anatolyevich Balyanov , Deputy Director of the Coordination and Information Center of the CIS Member States for the Convergence of Regulatory Practices. According to the UN, the volume of chemical production will double from 2017 to 2030. At the same time, there are also planetary crises associated with pollution by chemicals and waste, climate change and loss of biodiversity. Against this background, it remains important to develop documents regulating the safety of chemical products. The main requirements of the TR "On the Safety of Chemical Products" include identification of CP, safety data sheet, labeling, registration of CP, notification of CP and restrictions on circulation. The speaker also presented the areas of application to which the technical regulation applies and does not apply.

Alexey Aleksandrovich Shpilman , Director of the AI ​​for Science Center at Sberbank PJSC, spoke on the topic of "The Future of AI in Chemical Science" . Using the example of a presentation generated by artificial intelligence on the role of AI in the chemical industry, the expert commented on each of the slides. For example, artificial intelligence created high-quality images for the presentation, but the weaknesses include the insufficient reliability of information from sources. The expert believes that at present, AI technologies cannot completely autonomously and correctly create materials without human intervention. The speaker also noted that the topic of quantum computing for chemical reactions and generative AI are really relevant for use in the chemical industry.

Pavel Yuryevich Rakcheev , Deputy Operations Director for Promotion of Lumex Group, spoke about the interaction of Russian analytical instrumentation with laboratories and shared the experience of Lumex Group . The speaker presented an algorithm for the development, production and sale of devices, which includes 8 stages, and also spoke about the methodological support of analytical laboratories, which looks like this: TOR for development → Development (analysis scheme) → Certification (certificate) → MVI Register → TR CU, TR EAEU. The expert also noted that 32 national standards (GOST R) and 26 interstate standards (GOST) have been developed based on the methods of Lumex Group.

Round table on issues of ensuring the uniformity of measurements

The partners of the event are the Federal State Budgetary Institution "Research Center for PM - Rostest" and the Association "Roskhimreaktiv". The event began with the presentation of awards to the participants of the Federal State Budgetary Institution "ROSTEST-MOSCOW" competition: "For ensuring high accuracy of measurements in analytical chemistry".

Olga Dmitrievna Ermilenko , Deputy Head of the Department of Scientific and Methodological Foundations of the Activities of Metrological Services in the Sphere of State Regulation, spoke about changes in the legislation of the Russian Federation on ensuring the uniformity of measurements from March 1, 2025. The changes affected a number of points of the federal law, including:

• Amendment to Part 2 of Article 1 - clarification of the circle of persons to whom the provisions of the Federal Law apply
• Amendments to paragraphs 8, 13, 14 of Part 3 of Article 1 - changes in the sphere of state regulation of ensuring the uniformity of measurements
• Supplement of part 3 of article 1 with paragraph 20
• Amendment of Article 2, paragraphs 12,18 - clarification of basic concepts and definitions
• Amendment to Part 2 of Article 5 - Changes in Measurement Requirements

Seminar "Procedure for laboratories to undergo inspections by government agencies. Requirements and implementation"

The partner of the event is the ZNANIE Competence Center. The moderator was Inna Andreevna Vlasova, PhD in Biology, technical expert of Rosaccreditation, member of the All-Russian Quality Organization, quality director of ZNANIE Competence Center LLC. Tatyana Konstantinovna Usova , accreditation expert of Rosaccreditation, lecturer of ZNANIE Competence Center LLC, spoke on the topic "Technique for assessing the conformity of testing laboratories (centers) by an expert group during accreditation, expanding the scope of accreditation, confirming competence in Rosaccreditation in 2025" . The expert presented a guide to assessing the conformity of testing laboratories (centers) with the accreditation criteria SM No. 03.1-1.0018 version 01.3 December 2024:

1. General Provisions (General Policy for Accreditation of Testing Institutes, Assessment Techniques)
2. Evaluation Planning (Developing an Evaluation Plan)
3. Preparation for the assessment (Preparation by the expert group, Selection of objects of assessment by the OA, Preparation for the witness assessment)
4. Conducting conformity assessment during accreditation (expansion of OA, PC during the 1st year, PC every 2 years, PC every 5 years, witness assessment)
5. Preparation of reports (Expert opinion, Report of on-site examination, Report of examination, Report on witness assessment)
6. Development of an accreditation cycle assessment program (Appendices 1-8)

The speaker commented in detail on each stage of the assessment.

Elena Vladimirovna Lebedinskaya , Deputy Director General of the Federal State Budgetary Institution "Institute of Standardization", made a report "Implementation of the requirements of the accreditation criteria for testing laboratories in terms of the availability of standardization documents" . The expert noted that document management is an important component of the overall organization management process. The speaker commented on GOST ISO / IEC 17025-2019 "General requirements for the competence of testing and calibration laboratories", noting paragraphs 8.3.2, 6.6 and others, Article 30 of the Federal Law "On Standardization in the Russian Federation" N 162-FZ dated June 29, 2015 and the official websites of departmental institutions.

Larisa Evgenievna Berezova , First Deputy Director of the Federal State Budgetary Institution "TsLATI for the Central Federal District", spoke on the topic "Laboratory Support for Environmental Monitoring" . There are the following types of testing laboratories:

• State
• Departmental, including production
• Commercial

The speaker also listed the types of state control and requirements for testing laboratories participating in environmental control:

1. Clause 3 of Article 1 of the Federal Law of 26.06.2008 No. 102-FZ "On Ensuring the Uniformity of Measurements" (The scope of state regulation of ensuring the uniformity of measurements extends to measurements for which mandatory metrological requirements have been established for the purposes specified in Clause 3 of Article 1 and which are carried out in the course of activities in the field of environmental protection).
2. Clause 1 of Article 5 of the Federal Law of 26.06.2008 No. 102-FZ "On Ensuring the Uniformity of Measurements" (Measurements related to the sphere of state regulation of ensuring the uniformity of measurements must be performed using primary reference measurement methods (techniques), reference measurement methods (techniques) and other certified measurement methods (techniques), information about which is entered into the Federal Information Fund for Ensuring the Uniformity of Measurements, using measuring instruments of an approved type that have passed verification).
3. Resolution of the Government of the Russian Federation of 16.11.2020 No. 1847 "On approval of the list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements."

Larisa Berezova also presented instructions for testing laboratories involved in environmental monitoring and drew attention to Article 81 “Sampling” of Federal Law No. 248 “On state control (supervision) and municipal control in the Russian Federation”.

Results of events at the SMARTLABFORUM site

The partner of the SMARTLABFORUM platform is GenoLab.

Seminar "Creating a laboratory from scratch or expanding to a new location of operations - what is important to consider"

Inna Andreevna Vlasova , PhD in Biology, technical expert of Rosaccreditation, member of the All-Russian Organization for Quality, Director of Quality at ZNANIE Central Committee, spoke on the topic of "Key Points in Laboratory Accreditation or Expanding the Scope of Accreditation to a New Location of Operations". The speaker commented on Federal Law No. 412 "On Accreditation in the National Accreditation System", defining the concepts of accreditation and expanding the scope of accreditation. According to the expert, the algorithm for expanding the scope of accreditation is similar to the process of laboratory accreditation. Inna Vlasova notes that accreditation is mandatory for laboratories performing tests/measurements for the purposes of mandatory conformity assessment and laboratories performing tests/measurements in the field where the obligation to be accredited in the NSA is established. Voluntary accreditation applies to other laboratories, for example, research laboratories, for assessing the company's technological process and image component.

Forum of specialists in quality and registration of medicines

Partner — GxP Training Center. Dmitry Aleksandrovich Chukhaev , Validation Engineer at Astrapharm Group of Companies, spoke on the topic of "Risk Management in the Framework of Pharmaceutical Activity Quality Audits" . The expert presented the types of quality audits according to the ISO 9000 series standards:

1. Third party audit (external audit) – government inspection or verification carried out by a non-governmental certification body
2. Second party audit (external B2B audit)
3. First party audit (internal audit) – self-inspection, quality audit

Regulatory and legal documentation is presented:

• Federal Law of 10.04.2010 No. 61-FZ "06 Circulation of Medicines"
• Decision of the EEC Council dated 03.11.2016 No. 77 “On approval of the Rules of Good Manufacturing Practice of the EAEU” (with subsequent amendments)
• Recommendation PIC/S.P1:037-1-A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT

The expert then reviewed in detail the PIC/S PI 037-1 document, which is a simple and flexible approach to planning and conducting pharmaceutical inspections. The document is based on the concept of identifying risks and quantifying them in relation to patients, consumers, animals and users of drugs. The speaker also presented the Deming PDCA cycle and scheme, as well as risk assessment matrices and risk assessment methods used in quality risk management.

Seminar "Falsification, identification and assessment of composition. Legislation, control and problems, and casuistry of interpretation"

Partner: V. M. Gorbatov Federal Scientific Center of Food Systems. The moderator was Natalia Vostrikova, Doctor of Technical Sciences, Head of the Research Center of V. M. Gorbatov Federal Scientific Center of Food Systems of the Russian Academy of Sciences.

Yulia Kuzlyakina , PhD, standardization expert, expert in forensic regulatory examination, responsible secretary of TC/MTC 226 "Meat and Meat Products", head of the "Technical Regulation" department of the Research Center of the Federal State Budgetary Scientific Institution "V.M. Gorbatov Federal Scientific Center of Food Systems" of the Russian Academy of Sciences, spoke on the topic "Legislative aspects of using the term "falsification" . The speaker mentioned the regulatory framework, as well as the differences between the term "falsification" and the concept of "non-compliance with requirements". The expert gave examples of falsification of meat products, and also presented draft amendments No. 2 to TR CU 034/2013, which plans to establish the maximum permissible level of DNA components in the composition of meat products and the concept of "technological impurity of animal origin".

Yulia Yushina , Doctor of Engineering Sciences, Deputy Head, Expert of Forensic Regulatory Expertise of the Research Center of the Federal State Budgetary Scientific Institution "V.M. Gorbatov Federal Scientific Center of Food Systems" of the Russian Academy of Sciences, gave a report "Identification of the Composition of a Food Product by the Histological Method: Aspects of Falsification and Contamination, What Does a Histologist See?" The speaker mentioned the new standard GOST 34989–2023 "Meat and Meat Products. General Requirements and Procedure for Identification of Composition by the Histological Method" and commented on the main areas of application of microstructural studies, including the identification of mechanically separated meat, studies of bulk components, detection of signs of freezing, heat treatment, etc. Histological analysis is also used for other types of food products, since the method is adapted and validated depending on the matrices. Yulia Yushina also presented the microstructures of several examples of meat and dairy products.