RISK-BASED APPROACH IN DRUG QUALITY CONTROL

А.B. Voitenko, Т.А. Soldatenkova, Ya.V. Denisova, V.F. Sopin

Abstract. In the context of rapid development of pharmaceutical industry and the demand for these products by the population, issues related to ensuring the safe storage of medicines are becoming extremely relevant. Improper storage can lead to lost potency of active pharmaceutical substance, changed physico-chemical drug properties and its deteriorated structure, decreased effectiveness, and even possible toxic effects when using a medicine, which poses a danger to the health of patients.

Keywords: medicines, storage, quality stability, innovative solutions, risks.

CERTIFICATION OF GOODS AND SECONDARY MATERIAL RESOURCES

А.А. Nikanorova, D.А. Lebedev

Abstract. The issues of waste recycling and reduction have recently become especially relevant due to deterioration of the environmental situation in the world. The article examines the peculiarities of secondary raw materials and secondary material resources certification in our country, and also considers the experience of European countries and China.

Keywords: secondary raw materials, secondary material resources, recycling certification, waste certification.

HACCP SYSTEM AND THE NEW VERSION Of GOST R 51705.1-2024. PART 2

V.L. Arshakuni

Abstract. The article discusses the new edition of GOST R 51705.1-2024. When forming a HACCP system at an enterprise, it is advisable to divide its documents into four sections in accordance with the sequence of their development. The first part of the article describes the first and second sections. In the second part, the author considers the third and fourth sections and comments on each subsection.

Keywords: HACCP, management system, management measures, critical control point, hazard, hazard factor, food safety, technical regulations, criteria of action.

OPTIMIZATION OF ALGORITHMS FOR PRODUCTION TESTING PROCESSES IN MICROBIOLOGICAL RESEARCH LABORATORY

I.V. Ivanov, E.A. Berseneva, M.B. Nikitina, N.E. Cherepakhina

Abstract. The article discusses the scientific rationale for optimizing the algorithms of production processes for microbiological research and testing of medical devices using process approach.

Keywords: optimization, algorithm, process approach, testing, quality and safety indicators of medical devices.

STANDARD SAMPLES FOR THE ANALYSIS OF TOXIC BIOLOGICAL MATERIALS

А.М. Malov

Abstract. The article considers standard samples of the composition of biological media containing toxic metals, and their role in biomedical analytics. With the experience of creating such products at Golikov Scientific and Clinical Center of Toxicology (Federal Medical and Biological Agency), the author examines the features of the technology for obtaining reference materials as the basis for standard samples.

Keywords: standard samples, biomedical analytics, technologies, toxic metals.

EXPERIENCE IN REDUCING LOSSES OF ROUNDWOOD SUPPLIERS IN THE REPUBLIC OF MARI EL

O.G Tarasova, A.A. Karpov, A.D. Savina

Abstract. Continuing the theme of wood material chemical safety, touched upon by V.B. Khabarov et al., the authors consider methods for calculating round timber volume. To reduce mutual losses of suppliers and consumers when measuring the volume of sold products and ensuring the round timber turnover accuracy, an experience is proposed of using full-weight coefficients depending on the vehicle type.

Keywords: round timber, stack volume, full-weight coefficients, vehicle parameters.

PROBLEMS AND FEATURES OF EDUCATING STUDENTS OF ENGINEERING AND TECHNICAL SPECIALTIES ACCORDING TO “METROLOGY, STANDARDIZATION AND CERTIFICATION” DISCIPLINE

O.V. Puchka, V.S. Bessmertnyy, E.S. Chernositova, E.V. Chernysheva

Abstract. The article is devoted to the peculiarities of teaching the “Metrology, standardization and certification” discipline at a technical university. The author’s view on the aspects of conducting lectures, laboratory, practical and seminar classes for students of various specialties is proposed, based on many years of experience.

Keywords: regulatory documentation, conformity assessment, declaration, product and service certification, metrological services of organizations.