Introduction. There are presented data on drugs development with M.D. Mashkovskii lead. There are given materials on drugs belonging to important pharmacotherapeutic groups of drugs such as generic and original drugs. Original syntheses of famous generic drugs and improved industrial technologies have been developed. The attention is paid to high quality of produced drugs. More than 200 new molecules were synthesized while developing original structures of nitrobenzamide derivatives. The studies of pharmacological and toxicological characteristics have helped to choose and create original antiarrhythmic nibentan and niferidyl. The drugs are registered in the Ministry of Healthcare of the Russian Federation and included in essential drugs list.

Text. VNIKHFI branch called today VNC BAV founded in 1966. M.D. Mashkovskii offered that creation to expand scientific and experimental base of drugs development. It continues to research and develop new drugs including syntheses of original molecules, developing of industrial technology, and preclinical research of pharmacological activities, drug safety, and toxicology. Original synthesis schemes are described shortly in the article. Industrial technologies of pharmacopoeial substance synthesis are developed out of these schemes such as γ-butyric acid, dopamine, analgin for injection, and original drugs nibentan – ((RS) N-[5-(diethylamino)-1-phenylpentyl]-4-nitrobenzamide hydrochloride), niferidyl – N-1-[(4-fluorophenyl)- 2-(1-ethyl-4-piperidyl)ethyl]-4-nitrobenzamide hydrochloride. The release of developed drugs to the national industrial production is specially noted.

Conclusion. M.D. Mashkovskii always supported national drugs development by submitting valuable offers, paying constant attention to scientific research, quality of drugs, and drugs production in industrial quantities for securing national healthcare with national drugs.

Introduction. Single-domain antibodies (nanobodies) are composed of the heavy-chain variable domain only. Compared to conventional immunoglobulins G (IgG) nanobodies have such qualities as: high bioavailability, ability to bind epitopes that are difficult to reach, high solubility and thermal stability, etc. Nanobodies can be easily manufactured in microorganisms (E. coli) to significantly save on cost.

Text. Goal of the paper consists of the description of structural and functional properties of nanobodies and its effective application.

Conclusion. Nanobodies can be used in many fields of medicine and biotechnology such as research, diagnostics and therapy of oncology, infectious, hematological, inflammatory, autoimmune and neurological diseases. They can also be easily modified using another nanobody, molecules or radioactive mark as necessary. Nanobodies have huge potential for applications in diagnostics, therapy and medicine.

Introduction. Use of medicinal species at home entails some inconvenience. Therefore, it is topical to obtain phytopreparations, in particular dry extracts, from medicinal plant raw materials. This ensures the maximum yield of a complex of biologically active substances, and simplifies the way of its application, dosing and storage. The department of pharmacy of the Altai State Medical University has developed a specie of the following composition: dandelion medicinal herb and large burdock leaf (1:1). On the basis of this species, a technology for obtaining the dry extract is being developed. Variety factors influence on the output of a complex of biologically active substances from plant raw materials: the technological properties of raw materials, the methods and conditions for carrying out the extraction process, and the equipment used.

Aim. To determine the optimal conditions for extracting a specie of dandelion herb and a large burdock leaf.

Materials and methods. To solve this problem, methods of mathematical planning of a multifactorial experiment have been used: simplex method of mathematical planning, incomplete factorial experiment of type 2^5-2 for compiling the equation of the response surface, the method of steep ascent (the Box – Wilson method) along the response surface. Based on the theoretical basis of extraction, parameters and factors of process optimization were chosen, intervals of their variation are indicated. Variable factors – shredding, the ratio of «raw materials : extractant», time of maceration, temperature and the number of maceration. The extraction was carried out by remaceration, aqua purificata serves as extractant. The parameter of optimization was the exhaustion of the specie of extractive substances. Results and discussion. As a result of the simplex method, a number of studies were carried out until the area of the supposed optimum was reached. To describe the experiment in the region of the optimum and to compose the equation of the response surface, an incomplete factor experiment of the type 2^5-2 were put. A linear equation of the extraction process were obtained and the adequacy of the work of the obtained mathematical model is proved. To refine the extraction conditions and establish the optimal extraction regime, the method of steep ascent on the response surface was used.

Conclusion. As a result of the experiment, optimal extraction conditions were established: crushing – 2 mm, ratio «raw material : extractant» – 1:10, time of maceration – 30 minutes, number of maceration – 3, temperature – 100 °С. These results will be used in the development of technology and the technological scheme for obtaining the dry extract of the specie.

Introduction. When developing drugs it is necessary to use laboratory equipment that simulates pilot and industrial equipment. For the production of semi-solid preparations the key equipment are rotor-stator dispersers and vacuum reactors-homogenizers.

Aim. Investigation of the functional characteristics of laboratory equipment: Megatron® MT 1-50 dispersant SHS F/2 (Kinematica AG, Switzerland) and the RP-5 vacuum homogenizer reactor (Promvit, Ukraine).

Materials and methods. During development a generic product Penciclovir cream 1% the initial particle size in suspension of penciclovir and particle size after grinding were studied by optical microscopy and laser diffraction methods. In a cream made in the reactor, the particle size of the dispersed phase of the o/w emulsion and suspension, as well as the absence of air bubbles, were determined by optical microscopy. The assay of penciclovir in 9 samples of the cream taken from the reactor-homogenizer was performed by liquid chromatography. By the of rotational viscometry method the rheological properties of the cream were studied. By the inductively coupled plasma atomic emission spectroscopy the getting of metal impurities from the disperser and the reactor-homogenizer into the suspension and cream were investigated.

Results and discussion. With an increase in the rotor speed, the particle size of penciclovir in suspension decreases. The disperser effectively performs its function at a rotor speed of 25,000 rpm. In a cream made in the reactor, the deviations in the quantitative content of penciclovir from the average value in each sample are within the uncertainty of the analytical procedure, which indicates its uniform distribution. The reactor provides effective dispersion and uniform distribution of the oil phase, prevents the formation of a gas emulsion and allows getting a cream that, according to its rheological properties, corresponds to the reference preparation Fenistil® Pencivir cream 1%. In the production process metal impurities were not emitted into the suspension and the cream from the equipment.

Conclusion. The disperser and the reactor during the production of cream with penciclovir are suitable for their intended use. It is rational to combine these two types of equipment at the sites for the production of semi-solid preparations. The disperser can also be used to produce emulsions with a very small particle size of the dispersed phase.

Introduction. Currently, it is considered that the sea buckthorn genus includes 15 species and subspecies, but only 4 of them have found wide application in practice: the Chinese subspecies (sinensis), the European (rhamnoides), Central Asian (turkestanica) and Siberian (mongolica). Fruits of sea buckthorn have a complex chemical composition, represented by such groups of biologically active substances (BAS), as flavonoids, amino acids, organic acids, tannins, water- and fat-soluble vitamins, polysaccharides, easily digestible sugars. Most varieties of sea buckthorn bred in the Institute of horticulture Siberia M. A. Lisavenko. However, the biochemical composition of varieties adapted for growing under the conditions of the middle zone of the European part of Russia is little studied.

Aim. The work was to study the BAS profile of the sea-buckthorn fruits of various varieties growing in the middle zone of the European part of Russia, by capillary electrophoresis.

Materials and methods. The study of the profile of biologically active substances (free organic acids and sugars, as well as free and related amino acids) of sea buckthorn fruits of various varieties was carried out by capillary electrophoresis. The determination of the amount of free organic acids, amino acids, free and related sugars.

Results and discussion. Different varieties have their phytochemical features. The sugar-acid index of the sea-buckthorn fruits of the studied varieties varied from 0.9 to 2.01, which indicates that they belong to the acidic group according to the existing gradation.

Conclusion. In general, the qualitative composition of the BAS of the studied varieties is similar to each other, but it differs quantitatively. Identified varieties with a maximum and minimum content of the studied groups of biologically active substances.

Introduction. Drug delivery systems are defined as systems that deliver the optimal amount of a drug to a target target, increase the effectiveness of treatment, and reduce adverse effects. Regulation of the rate of release of drugs and bringing to specific tissues where active ingredients are needed are the main objectives of drug delivery systems. The development of systems for targeted, organ-specific and controlled delivery of medicinal, prophylactic and diagnostic agents is currently a relevant area of research for pharmacy and medicine. Of particular interest is the actual problem of increasing the frequency of manifestations of side effects of drugs. The side effect of drugs, their low efficiency is often explained by the inaccessibility of drugs directly to the target.

Text. Currently, targeted delivery of chemotherapeutic agents and drug delivery systems has completely changed the tactics and approaches in the drug treatment of cancer, allowing to reduce the side effects of the drug and generally increase the effectiveness of the course of treatment. This paper summarizes and systematizes information about targeted systems for drug delivery of antitumor activity, described in the scientific literature and used in pharmacy and medicine. Most of the methods for obtaining cellular forms of toxic drugs discussed in this review are still at the development stage, and some methods are gradually finding practical application abroad in medicine and other fields. Vincristine (VCR) and vinblastine (VBL) are the most widely used and effective drugs in chemotherapeutic practice. Despite their effectiveness against various oncological diseases, there are a number of harmful side effects that limit the widespread use of these drugs.

Conclusion. There is the possibility of using cellular carriers as a VCR and VBL delivery system. In scientific publications, there is still no data on the use of cellular carriers for encapsulating VCR and VBL. Therefore, relevant studies are devoted to the possibility of using cellular carriers to reduce side effects, improve efficiency, and develop dosage forms for the delivery of VCR and VBL to pathological foci. This topic is currently being actively developed by members of the Department of Pharmaceutical Chemistry and Pharmaceutical Technology, Pharmaceutical Faculty, Voronezh State University.

Introduction. One of the most promising synthetic compounds of coumarin derivatives is immunacor-4,4'-dimethyl-7,7'-ethylenedioxy-2H-1-dibenzopyran-2,2'-dione. As a result of preclinical studies, it has been shown that it is promising in medical practice as an immunomodulator for the treatment and prevention of secondary immunodeficiency diseases.

Aim. The objective of this work is to develop methods for HPLC and UV spectrophotometry to determine the quantitative determination of the immunacor substance and to study the complex of validation characteristics of the developed methods.

Materials and methods. Quantitative analysis of the substance was carried out by UV-Spectrophotometry and HPLC. Validation procedures were performed on parameters: specificity, linearity, accuracy and precision in accordance with the requirements of FP XIV.

Results and discussion. Validation characteristics have been determined, and their compliance with the relevant eligibility criteria has been experimentally verified.

Conclusion. Methods for quantitative determination of the active component in 4,4'-dimethyl-7,7'-ethylenedioxy-2H-1-dibenzopyran-2,2'-dione (immunacor) pharmaceutical substance by HPLC and UV spectrophotometry has been developed. It is established that methods are specific, accurate, precise and linear in the analytical field. The precision HPLC method far exceeds the UV-spectrophotometry.

Introduction. The object of analysis was a newly synthesized organic substance, a derivative of 4-aminobenzoic acid and malonic ester  – 4,4’-(propandiamido) sodium dibenzoate, which has an antisteatotic effect. For the quantitative determination of pharmaceutical substances, it is preferable to use titrimetric methods of analysis, since they are absolute and allow us to estimate the content of the active compound in the substance without using standard samples.

Aim. The objective of this work was to develop and validate a quantitative determination method for 4.4’-(propandiamido) sodium dibenzoate.

Materials and methods. The analyzed compound is a salt of a weak dibasic acid, which exhibits basic properties in an aqueous solution; therefore, for its quantitative determination, a direct acid-base titration method (acidimetry) was proposed. The method of quantitative determination of the active compound in the substance 4,4’-(propandiamido) sodium dibenzoate will be used in future studies for routine analysis, therefore a visual (indicator) method for determining the end point of the titration has been chosen. To prove the suitability of the developed method and the possibility of obtaining reliable results of the quantitative content of the active compound in the newly synthesized pharmaceutical substance the used analytical method was validated.

Results and discussion. The study of the acid-base properties of the newly synthesized substance was carried out using the method of potentiometric titration, on the basis of which the values of the dissociation constants were calculated. Using spreadsheets, the pK_a1 and pK_a2 values were calculated using a titration model of a multi-basic acid, the pKa values of which are 7.2 and 5.0. The titration curve that was constructed from the experimental data and the curve constructed from the calculated values of the dissociation constants almost completely overlapped with each other. Based on the data obtained, a 0.1% water-alcohol solution of bromocresol green (blue) with pT=4.6 was selected for titration, the color transition interval of which falls into the titration jump of the analyte. The developed methodology was validated according to the requirements of the XIV edition State Pharmacopoeia of the Russian Federation by the following indicators: specificity, linearity, accuracy, precision (convergence and internal reproducibility), robustness, analytical domain.

Conclusion. As a result of the performed studies, the values of acid dissociation constants of the newly synthesized pharmaceutical substance 4,4’-(propandiamido) sodium dibenzoate were determined, and a method for quantitative determination was developed and validated using acid-base titration.

Introduction. Radionuclides are recognized as one of the most dangerous pollutants of a surrounding medium in forces of their fissile migration on biological chains and influences on metabolism of alive organisms now.

Aim. Studying of accumulation of radionuclides and polysaccharides in roots of a burdock big, collected in the territory of the Voronezh region in the areas which are influenced various anthropogenic influence and also an interrelation research between accumulation of these groups of substances.

Materials and methods. The raw material was collected in the territory of Voronezh Region in the areas with different anthropogenic impact. Based on cartography the 36 points of the medicinal vegetable raw material samples collection were chosen in Voronezh Region. The subject matter was the roots of the Greater Burdocks as a wide spread perennial plant. The main artificial (Sr-90 and Cs-137) and natural (K-40, Th-232 and Ra-226) radionuclides as well as a concentration of the total amount of polysaccharides in terms of fructose and the total amount of gravimetrically determined polysaccharides were defined in the samples.

Results and discussion. All the samples met the requirements of the pharmacoeial article of the artificial radionuclides content. A content of the total amount of polysaccharides in terms of fructose determined by spectrophotometry significantly varied in the root samples depends on their collection point. Thus, in protected reserved areas a content of the total amount of polysaccharides in term of fructose was 30-45 % high than in the samples from ecologically unfavourable areas. However all the samples also met the requirements of the pharmacoeial article of the total amount of polysaccharides in terms of fructose. A content of the polycaccharides close to the lower norm was found out in a sample collected in Povorino, while a content of the polycaccharides in terms of fructose significantly exceeded the normative standard in the rest of the samples. A content of gravimetrically determined water-soluble polysaccharides in the roots varied from 21,17 to 37,82 %. No noticeable anthropogenic effect on the accumulation of these substances was found. The samples from ecologically unfavourable and protected areas were little different from each other in a quantitative content of water-soluble polysaccharides.

Conclusion. The correlation coefficients between the content of radionuclides and major groups of bioactive substances in the roots indicated that the radionuclides accumulated in the greater budock roots in a minor amounts and they did not affect the content of bioactive substances in plant raw material.

Introduction. Cytochrome C is a metabolic drug that has an antihypoxic, trophic effect, stimulates regeneration processes, and is also used in various eye diseases.

Aim. The task of the work was to determine the specific activity of cytochrome C eye drops in comparison with emoxipin.

Materials and methods. As a test system, Soviet chinchilla male rabbits were used, the simulation of traumatic erosion and acid burn was carried out, followed by the use of test eye drops. In forming erosion, the method of C. Hanna, J. E. O'Brien (1960) with scraping of the corneal epithelium, an acid burn in the experiment was formed under local anesthesia (0.4% inocain) application of filter paper (in the form of a circle with a diameter of 8 mm) moistened with 3% acetic acid solution with an exposure of 5 seconds on the cornea. The effectiveness evaluation was carried out on the basis of a scale proposed by the authors, which allows histologically to take into account corneal changes during the pathological process. Descriptive statistics methods were used for all quantitative data: the average sample values (M) and standard deviations (SD) were calculated. The distribution in each data sample was analyzed using the Shapiro – Wilk criterion. Under normal distribution, analysis of variance was used followed by a posteriori analysis (Tukey criterion). If the data had an abnormal distribution, the Kruskal-Wallis test was calculated.

Results and discussion. The integrity of the patterns of traumatic erosion and acid burn was histologically confirmed. The therapeutic efficacy of eye drops of emoxipin in the full dose was not sufficiently pronounced and comparable to that of cytochrome C in half the therapeutic dose. Cytochrome C in therapeutic and dual therapeutic dose effectively coped with the effects of acid burn and traumatic erosion when used in the form of eye drops for 28 days.

Conclusion. Cytochrome C eye drops, used at a therapeutic dose and a dose exceeding the therapeutic dose 2 times, have a pronounced regenerative effect in traumatic erosion and acid burn of the rabbit eye cornea. The effect of Cytochrome C eye drops at half the therapeutic dose, as well as the reference drug (emoxipin) at the therapeutic dose, is not very pronounced.

Introduction. Nootropic drugs are components of complex therapy for various neurological dysfunctions. One of the classes of ND are pyrrolidone derivatives, which, in addition to a direct effect on cognitive functions, increase the brain's resistance to hypoxia.

Aim. The work was to study the effect of the 3-aminopyrrolidin-2-one derivative containing the norbornane fragment (P-11) on different memory phases in rats and to evaluate its antihypoxic properties.

Materials and methods. The effect of P-11 on memory was assessed on passive avoidance test (PAT) in rats. The antihypoxic properties of P-11 were studied on a model of acute normobaric hypoxia with hypercapnia, assessing the life span of laboratory animals and the level of lipid peroxidation processes in the brain.

Results and discussion. It was shown that the introduction of P-11 at different stages of the development of passive avoidance reaction improves the ability of animals to learn and extract a memorable trace of pain stimulation 24 hours after the development of a reflex. On a model of normobaric hypoxia with a single injection, P-11 showed a tendency to increase the life span of rats relative to the control, and with a 14-day treatment, pronounced antihypoxic properties were observed compared with other pyrrolidone derivatives, pyracetam and phenotropil, which manifested in an increase in life span of mice, as well as in lowering lipid peroxidation processes in brain tissue.

Conclusion. Thus, it was shown that a new derivative 3-aminopyrrolidin-2-it exhibits nootropic and antihypoxic properties.

Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required.

Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post – registration period. The first post-registration changes in the regulatory documentation were administrative in nature and did not require examination of samples of the drug. The next group of changes in the documents of the registration dossier was due to the expansion of production, reconstruction of technological sites and the introduction of innovative technologies in order to comply with the requirements of GMP, as well as improving the consumer properties of the drug. The last group of changes concerned the revision of methods of quality control of finished products associated with the introduction of modern analytical equipment, expanding the list of standards and bringing into compliance with the requirements of the state Pharmacopoeia XIII edition.

Conclusion. The timely introduction of changes into documents of the registration dossier allows you to optimize the procedure for the conduct of internal and external control of rabies immunoglobulin, as well as to avoid violations related to the actualization of the technological documentation. The analysis of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post-registration period. Timely changes in the documents of the registration dossier allow to optimize the procedure of internal and external quality control of anti-rabies immunoglobulin, as well as to avoid violations associated with the updating of technological documentation.

Background. The most effective anorexic drugs on the pharmaceutical market are sibutramine. According to the standard scheme, sibutramine is similar to amphetamine. The active metabolites of sibutramine, formed in the process of its metabolism, have high pharmacological activity compared with the original substances, so the drug may be toxic to the body. Sibutramine is used in the complex treatment of obesity, when adjusting excess body weight in type II diabetes, and also used in polycystic ovary syndrome. The drug has many serious undesirable side effects, such as an increase in systolic and / or diastolic pressure and heart rate; headaches, insomnia, disorders of the gastrointestinal tract and can cause death. In many countries of the world a wide range of serious side effects has been banned.

Text. A description of the drug sibutramine, its status on the pharmaceutical market of the Russian Federation and other countries of the world, an overview of possible methods for determining sibutramine in food supplements.

Conclusion. Recently, information about the undeclared addition of sibutramine to the anorexigenic dietary supplement (dietary supplement) to increase their effectiveness has increasingly appeared. Therefore, it is necessary to develop methods for determining sibutramine in anorexic dietary supplements. In this regard, an analysis of the methods used for the quantitative determination of sibutramine. As a rule, spectral methods are used to determine the authenticity of a sibutramine substance. The most common and effective method for determining authenticity and quantitative analysis of sibutramine is the HPLC (high performance liquid chromatography) method using mass spectrometric and diode array detectors (DAD). At the moment, a method for determining sibutramine in the composition of multicomponent drugs and dietary supplements to food of anorexigenic action is being developed, which will contribute to the development of pharmacy.

Introduction. This article describes the procedure for personnel management in a pharmacy organization in terms of the current requirements of Good Pharmacy Practice (GAP) and Quality Management System (QMS). A key element of the NSP and QMS is staff, so the HR management system should be based on the principles and foundations inherent in these concepts and be adequate to the current quality system in the pharmacy organization.

Text. Quality management involves the use of systematic and process approaches. In doing so, pharmacies need to take a number of steps to improve the quality of the workforce, its activities and involvement in the process of formation of NPS and QMS. In addition, the professional development of staff is an essential condition and key to the successful functioning of the quality system, as well as the efficiency, performance and well-being of the organization as a whole. To implement the requirements of the quality management system, specialists of the personnel department, managers of all levels, as well as ordinary employees should be involved. Achieving a high level of quality management system at the enterprise is possible only in the presence of highly qualified personnel with certain competences. According to the requirements of Good Pharmacy Practice, which came into effect on March 1, 2017, the Pharmacy should implement the Personnel Adaptation Programme. Adaptation is a complex and time-consuming process of adjusting new employees to the content, working conditions and social environment of the organization, the gradual inclusion of new employees in the professional activities and team, and the pharmaceutical industry has its own characteristics and specifics. In the article the variant of the program of adaptation for the young employee including various aspects and forms of its carrying out which can render the essential help to heads of the drugstore organizations and experts of service of the personnel at training of new employees is offered. In addition to the adaptation program, the pharmacy organization should develop and implement a training system that corresponds to the specifics of the organization's production processes. The training needs of staff are determined by the training specialist, who annually and on a quarterly basis forms a schedule for external training of staff. The training schedule takes into account the plans for the development and updating of documents of the organization, which relate to the working activities of the employee. Training according to the documents is carried out by the head of the structural subdivision, the results of knowledge control should be recorded by him in the internal training cards of the employee. In contrast to the traditional approach to the organization of personnel training in the pharmacy organization, it is now rational to introduce standard and individual training matrices.

Conclusion. The authors express their vision of strategy, planning, professional growth management, training of new knowledge and skills of personnel in the quality management system.

Introduction. In case of methods of impurities determination quite often there are problems connected both with establishment and with check of implementation of the requirement to necessary sensitivity of a chromatographic system.

Text. Influence of correction factors and late eluting peaks of impurities on the requirement for the signal-to-noise ratio (S/N) for chromatographic system suitability testing is considered.

Conclusion. The recommendations are provided how to detect situations at which the requirement of S/N≥10 is insufficient for reliable detecting peaks of all impurities (related substances) and therewith how to correct concentration of test solution and/or the requirement to S/N for system suitability testing.

Introduction. In 2018 «Center of Pharmaceutical Analytics» LLC successfully passed the certification of quality management system for compliance with the requirements of ISO 9001: 2015 and GOST R ISO 9001-2015 «Quality Management System. Requirements».

Text. Certification was conducted by the Certification Association «Russian Register» – a Russian company, which is an accredited body for certification of management systems of organizations. This article describes the program of certification audit of the «Russian Register», which includes: certification, consisting of two stages, inspection checks during the first and second year and re-certification audit during the third year before the expiration of the certificate. The structure of works on confirmation of the certificate of conformity of «Russian Register» includes field audits designed to assess the degree of compliance of the organization with the established requirements of the standard for compliance with which certification was carried out [1]. The objectives of the certification audit were: verification of compliance of the management system with the requirements of ISO 9001: 2015 (GOST R ISO 9001-2015), verification of established processes and documentation of the management system of the organization; assessment of the ability of the management system to ensure compliance with applicable legislative, regulatory and contractual requirements; assessment of the effectiveness of the management system to ensure that the goals can be achieved; identification of areas for possible improvement of the management system. The audit was conducted over two days on processes and units related to the activities of the organization. The audit confirmed the scope of certification in respect of: research work, bioanalytical studies, pharmacokinetic studies, STCR (comparative text of dissolution kinetics). The scope of the audit included verification of adequacy, compliance of activities and elements of the management system, including: production, management and support processes; policies; goals; organizational structure of management; documentation of management system, analysis of measures taken by the organization to eliminate the problem areas identified at the 1st stage of certification [2].

Conclusion. In September 2018, the analytical center was issued certificates of compliance with the requirements of GOST R ISO 9001:2015 in the certification Association «Russian Register» with the accreditation of the Federal service for accreditation of the Russian Federation (Rosaccreditation); international standard ISO 9001: 2015 in the Certification system of the Russian Register, a member of the international forum on accreditation IAF; certificate of conformity.