Master degree program
Pharmaceutical Manufacturing Technology

Pharmaceutical Manufacturing Technology

QUALIFICATION

  • Scientific and pedagogical direction - Master of Engineering Sciences

MODEL OF GRADUATING STUDENT

Upon completion of this program, it is expected that undergraduates will be able to
1. Demonstrates interdisciplinary systems thinking to achieve their own successful and sustainable professional development and excellence in scientific, industrial and pedagogical activities.
2. develops, organizes and conducts the technological process of production of medicinal substances in accordance with the regulatory requirements of SP of the RK, taking into account the relationship of their structure, chemical properties and biological activity.
Organizes the production of drugs in various dosage forms using innovative technologies, conducting a critical analysis of chemical, technological, biopharmaceutical and medical research of drugs and medical devices in the development of their regulatory documentation, reporting on the validation of production technology and the establishment of stability.
4. Conducts a comparative analysis of the most rational, economically and environmentally sound technologies for the production of herbal medicinal products (phytopreparations), critically evaluating and justifying the choice of methodology and instrumental methods of their production in various dosage forms.
5. Demonstrates possession of modern physico-chemical methods of qualitative and quantitative determination of substances and excipients in drugs and on the stages of the technological process of their production, applying theoretical laws of quality control to the detection of counterfeit, substandard and counterfeit drugs, developing unified methods of analysis of functional groups of drugs, making scientifically substantiated choice of the set of necessary for identification of drugs and excipients.
6. Critically appraises excipients of drugs, reasonably analyzing their chemical structure, production technology and use in different types of dosage forms, taking into account their safety and synergistic interaction with substances.
7. Develops new medicinal substances taking into account their mechanism of action, carrying out the main stages of their production from research paper (RP) and research and development work (R&DW) to state registration, skillfully using international standards of regulatory and manufacturing documentation in pharmaceutical production.
8. Realizes the organization of pharmaceutical production in accordance with the requirements of Good Pharmaceutical Practices (GMP, GPP, GDP, GVP), critically evaluating and justifying the achievement of compliance and maintaining an appropriate level of product quality for the products previously manufactured by local or domestic standards, forming a conceptual plan for the introduction of drugs and medicines in production in compliance with international standards and proposing methods of their production, control, registration and pharmacological
9. Applies methods of directed design of life-saving drugs, taking into account the dependence of their type and level of physiological activity on the structure of the drug substances.
10. Demonstrates profound professional knowledge in the field of management and marketing in pharmacy, applying basic management functions in the management of pharmaceutical industry enterprises; carrying out analysis of the pharmaceutical market of different levels and on its basis building management strategy, modeling the system of pharmaceutical products promotion in the market, evaluating merchandising systems at pharmaceutical industry trade enterprises, designing merchandising systems of medicines in pharmacy enterprises.
11. Performs logistics system design in the pharmaceutical industry, modulating the logistics of procurement, distribution and sales, inventory and warehousing, manufacturing processes and transportation, information, finance and service in pharmaceutical enterprises, demonstrating the ability to scientifically design the tariff system in the pharmaceutical enterprise logistics system.
12. organizes pharmaceutical and medical products certification systems and facilities to examine the quality, safety and efficacy of drugs and medical devices in accordance with the requirements of Good Pharmacy Practices.

Program passport

Speciality Name
Pharmaceutical Manufacturing Technology
Speciality Code
7M07203
Faculty
Chemistry and Chemical Technology

disciplines

Creation and analysis of prolonged dosage forms
  • Number of credits - 5
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline: to apply the principles of creating polymer dosage forms of prolonged action, to explain the patterns of obtaining prolonged systems, to analyze the obtained dosage forms. The discipline forms the theoretical and methodological base of methods for creating prolonged dosage forms, the kinetics of the release of the active principle from the polymer base, methods for the analysis and control of prolonged dosage forms (solutions, gels, patches, films, etc.).

Foreign Language (professional)
  • Number of credits - 6
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline is to form practical skills in various types of speech activity in a foreign language. The training course builds the ability to perceive, understand and translate information in the modern global space, participate in scientific events to test their own research. The discipline is aimed at improving competencies in accordance with international standards of foreign language education.

Good Pharmaceutical Practice Standards
  • Number of credits - 5
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to form the ability to implement the standards of GPP in pharmaceutical production. Discipline forms a theoretical and methodological basis for the organization of pharmaceutical production in conditions of GPP, is aimed at studying international standards of good practices for monitoring the process of product development, production and quality through the use of effective monitoring and control systems.

History and Philosophy of Science
  • Number of credits - 3
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline is to form a holistic systemic understanding of philosophy as a special form of cognition of the world, its main sections, problems and methods of their study in the context of future professional activity. The training course forms the theoretical and methodological basis of research work.

Innovative technologies for the production of herbal medicinal substances and their standardization
  • Number of credits - 6
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to form the ability to apply innovative technologies in production of herbal medicinal substances and their standardization. Discipline forms the basis for selection of innovative technologies in production of substances from medicinal plants and their standardization, is aimed at studying the influence of innovative technological parameters on the effectiveness of isolation of medicinal substances and implementation of their standardization.

Innovative technologies for the production of synthetic medicinal substances and the establishment of indicators of their quality
  • Number of credits - 6
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to form the ability to apply innovative technologies for synthesis of drugs and determination of their quality indicators. Discipline forms a theoretical, practical base on the principles of developing innovative medicinal substances and establishing their quality indicators, is aimed at developing optimal individual, combined and flexible pharmaceutical production of innovative medicinal substances and drawing up their regulatory documentation.

Modern spectral methods for drug analysis
  • Number of credits - 5
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose:to generate the ability to identify drugs spectral analysis methods. Discipline forms the theoretical and methodological basis for the use of spectral methods for the analysis of medicines and is aimed at studying the methods of spectral analysis that allow identifying the fine structure of active, excipients and drugs obtained on their basis.

Organization and Planning of Scientific Research (in English)
  • Number of credits - 6
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline to form the ability to apply practical skills in the organization and planning of scientific research. The discipline studies: forms and methods of planning, organization and design of scientific articles and dissertations; forms of summarizing the results of scientific research in presentations, speeches, projects, articles.

Organization of pharmaceutical production in accordance with the rules of Good Pharmaceutical Practices
  • Number of credits - 9
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to form the ability to implement the standards of GPP in pharmaceutical production. Discipline forms a theoretical and methodological basis for the organization of pharmaceutical production in conditions of GPP, is aimed at studying international standards of good practices for monitoring the process of product development, production and quality through the use of effective monitoring and control systems.

Pedagogy of Higher education
  • Number of credits - 5
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline is to form the ability to teach in universities and colleges based on knowledge of higher school didactics, theory of education and management of education, analysis and self-assessment of teaching activities. The training course is aimed at studying the trends in the development of education and the Bologna process. The course will help you master teaching and curatorial skills, various strategies and methods of teaching and education.

Psychology of management
  • Number of credits - 3
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline is to provide scientific training of highly qualified specialists based on the study of fundamental concepts of management psychology, creating prerequisites for a theoretical understanding and practical application of the most important aspects of the field of management in the process of professional formation. The course is aimed at studying the patterns of development and functioning of mental processes, the basics of effective interaction and conflict resolution, self-development and self-presentation.

Data for 2022-2025 years

disciplines

Chemistry and problems of creating anticancer drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: form the ability to characterize the dependence of type and level of antitumor action of applied organic compounds on their structure. Discipline forms the theoretical, methodological basis for the classification, determination of action mechanism of various groups of antitumor drugs and is aimed at studying the structure and chemical properties of organic compounds used in chemotherapy, and the problems of their creation.

Chemistry and technology for producing neuroleptic drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: form the ability to characterize the methods of obtaining neuroleptic drugs and dependence of type and level of their neuroleptic activity on the structure of drugs. Discipline forms the theoretical, methodological basis for synthesis of neuroleptic drugs, is aimed at studying the functions and mechanism of action of neurotransmitters in body, studying the chemical properties of psychotropic drugs, evolution of their creation and application.

Chromatographic analysis of drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose:to form the ability to conduct chromatographic analysis of drugs and interpretation of data obtained. Discipline forms the theoretical and practical basis of the methodology of research and identification of medicines by modern methods of chromatographic analysis and is aimed at studying thin-layer, high-performance liquid, gas, gas-liquid chromatography, ion exchange and gel chromatography.

Creation and analysis of prolonged dosage forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose of the discipline: to apply the principles of creating polymer dosage forms of prolonged action, to explain the patterns of obtaining prolonged systems, to analyze the obtained dosage forms. The discipline forms the theoretical and methodological base of methods for creating prolonged dosage forms, the kinetics of the release of the active principle from the polymer base, methods for the analysis and control of prolonged dosage forms (solutions, gels, patches, films, etc.)

Design and production of polymer drug forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to develop the design and algorithm for obtaining polymer forms of medicines, to choose suitable polymer forms to meet the needs of modern medicine. Discipline forms the theoretical, methodological basis of methods for obtaining and features of the action of dosage forms based on polymers, is aimed at studying the history of drug design, the principles of creation, technologies used in this field.

Developing a registration dossier for medicines, their registration and pharmacological supervision
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to apply regulatory and legal norms to the production of medicines at the stage of their registration and pharmacological supervision. Discipline forms the regulatory and legal basis for the procedure for registration and pharmacological supervision of medicinal substances and medicinal products, and is aimed at studying the requirements for their state registration and pharmacological supervision.

Excipients production technology
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to analyze excipients, their structure, physicochemical properties, production and use. Discipline forms a theoretical and methodological basis in the field of chemical technology of excipients and their physiological role, is aimed at studying the classification of excipients, chemistry and technology of their production, their impact on the safety and pharmacological effect of substances of medicines.

Fundamentals of entrepreneurial activity and its state regulation
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: form the ability to apply the peculiarities of entrepreneurial activity and methods of its organization in pharmacy. Discipline forms the basis of ownership of entrepreneurial activity in pharmacy and its state regulation; is aimed at studying the objects of entrepreneurship in pharmacy production, regulatory support for entrepreneurial activity, strategic planning as a method of state regulation in pharmacy.

Fundamentals of Pharmaceutical Logistics
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to implement the requirements set on the management of material flow from source to consumer. Discipline forms the basis for modeling logistics systems, evaluating the economic efficiency of commercial logistics methods in pharmaceutical activities, is aimed at studying the logistics of material flows, technology of conducting the business procurement process, production logistics, their management at pharmaceutical enterprise.

Identification of fitodrugs and their biological activity
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to develop the ability to identify phytopreparations and determine their biological activity. Discipline forms a theoretical and methodological basis for identifying BAS of phytopreparations and establishing their biological activity, is aimed at studying methods of their functional analysis and interpretation of data from modern chromatographic and spectral methods of their analysis and biological activity.

Innovative technologies for the design of synthetic drug forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose:to form the ability to create, study and introduce innovative technologies in the production of synthetic dosage forms. The training course forms a theoretical and practical basis for the development and implementation of innovative dosage forms in production, aimed at studying methods and innovative pharmaceutical technologies, taking into account the latest achievements in related fields.

Innovative technologies for the production of synthetic drugs in various dosage forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose:to form the ability to create, study and introduce innovative technologies in the production of synthetic dosage forms. The training course forms a theoretical and practical basis for the development and implementation of innovative dosage forms in production, aimed at studying methods and innovative pharmaceutical technologies, taking into account the latest achievements in related fields.

Modern methods of chromatographic analysis of drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose:to form the ability to conduct chromatographic analysis of drugs and interpretation of data obtained. Discipline forms the theoretical and practical basis of the methodology of research and identification of medicines by modern methods of chromatographic analysis and is aimed at studying thin-layer, high-performance liquid, gas, gas-liquid chromatography, ion exchange and gel chromatography.

Modern physicochemical methods for the investigation of synthetic drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to form the ability to identify synthetic drugs by modern physical and chemical methods to ensure the control of their quality indicators. Discipline forms the theoretical, methodological basis of various directions in chemical analysis and factors determining the choice of analysis method, is aimed at studying atomic emission and fluorescence, refractometric, polarimetric, spectral, chromatographic methods of analysis.

Modern technologies in the production of fitodrugs in various pharmaceutical forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose to form the ability to develop modern technologies for the production of phytopreparations in various dosage forms. The discipline forms the theoretical and methodological basis for choosing the most rational, economically and environmentally sound technologies for the production of phytopreparations in various dosage forms, ensuring their biological safety and high efficiency.

Pharmaceutical and medical commodity science
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to merchandise thinking and analysis of medical and pharmaceutical products. Discipline forms the skills of conducting commodity analysis of pharmaceutical products, medical products, segmentation of the pharmaceutical market, selection of target segments,is aimed at studying the objects, subjects and methods of commodity science, the basics of commodity analysis, coding, standardization, the range of pharmaceutical products and their consumer properties.

Pharmaceutical developments and registration dossiers of medicines and medical devices
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: form the ability to explain the methodological principles of pharmaceutical development of drugs and medical devices, drawing up registration dossiers for their state registration. Discipline forms the theoretical and methodological foundations for the preparation of pharmaceutical developments and registration dossiers, is aimed at studying the preparation of regulatory documentation in accordance with international standards.

Pharmaceutical management and marketing
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: form ability to use methods of organizing work in main links of commodity distribution system of pharmaceutical market. Discipline forms the professional level of communication competencies in field of pharmaceutical management, is aimed at studying the characteristics of market, socio-economic characteristics of sphere of drug supply to population, the concepts of social, ethical marketing, principles of formation of marketing information systems in field of drug supply.

Pharmaceutical merchandising
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: form the ability to organize a pharmaceutical business and manage the pharmaceutical market. Discipline forms basis for use of management, marketing and merchandising functions in pharmacy, is aimed at studying merchandising as a means of communication, the laws and rules of product placement, conducting trade operations in the field of drug circulation, psychological aspects of communication between pharmacist and buyer.

Polymeric drug delivery systems
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose: to develop the ability to develop and design drug delivery systems based on polymers. Discipline forms the theoretical and practical basis for creating systems for targeted delivery of medicinal substances and prolonging their effect, is aimed at studying the types, methods and technologies of obtaining, mechanisms of operation of polymer drug delivery systems.

Prospects for the creation of effective and safe drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose - to develop the ability to characterize modern approaches to the creation of effective and safe drugs. Discipline forms a theoretical and methodological basis for development of new dosage forms of medicines, is aimed at studying the methods of targeted design of safe and effective medicines, their molecular modeling, virtual screening and design.

Prospects of developing chemistry and technology for the production of herbal medicines in various dosage forms
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - The purpose to form the ability to develop modern technologies for the production of phytopreparations in various dosage forms. The discipline forms the theoretical and methodological basis for choosing the most rational, economically and environmentally sound technologies for the production of phytopreparations in various dosage forms, ensuring their biological safety and high efficiency.

Spectral methods for the analysis of drugs
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose:to generate the ability to identify drugs spectral analysis methods. Discipline forms the theoretical and methodological basis for the use of spectral methods for the analysis of medicines and is aimed at studying the methods of spectral analysis that allow identifying the fine structure of active, excipients and drugs obtained on their basis.

Standardization and certification of medicines
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form theoretical knowledge and professional competence in field of concept of quality assurance of medicines. Discipline forms the theoretical, methodological basis for the standardization and certification of medicines,is aimed at studying the mechanisms and tools of state regulation of the quality of medicines, the rules of their certification and standardization in accordance with the requirements of GMP.

Study of the stability of drugs and medical devices
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: form the ability to determine the stability of medicinal substances, medicinal products and medical devices in process of their storage to establish their shelf life and storage conditions. Discipline forms the theoretical, methodological basis for determining the stability of pharmaceutical products during storage and is aimed at studying the stability of pharmaceutical samples while maintaining their quality indicators during storage.

Validation of analytical methods and pharmaceutical production technologies
  • Type of control - [RK1+MT+RK2+Exam] (100)
  • Description - Purpose: to form the ability to develop regulatory and legal documents and requirements for the validation of the production technology of medicinal substances, medicines and medical devices. Discipline forms the theoretical basis for validation of drug production technology and is aimed at studying the main features of validation, its parameters, requirements for its implementation and the processes to be validated.

Data for 2022-2025 years

INTERNSHIPS

Pedagogical
  • Type of control - Защита практики
  • Description - Formation of practical, educational-methodical skills of conducting lectures, seminars, creatively apply scientific, theoretical knowledge, practical skills in teaching activities, conduct training sessions in the disciplines of the specialty; own modern professional techniques, methods of training, use in practice the latest theoretical, methodological advances, make educational, methodological documentation.

Research
  • Type of control - Защита практики
  • Description - The purpose of the practice: gaining experience in the study of an actual scientific problem, expand the professional knowledge gained in the learning process, and developing practical skills for conducting independent scientific work. The practice is aimed at developing the skills of research, analysis and application of economic knowledge.

Data for 2022-2025 years