Regulatory Support of Biotechnology Industry

Major: Biotechnology and Bioengineering
Code of subject: 6.162.00.O.023
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Monka Nataliia Yaroslavivna
Semester: 4 семестр
Mode of study: денна
Мета вивчення дисципліни: The purpose of teaching the content module "Regulatory support of biotechnological production" is to provide students with basic knowledge of the basics of legislation governing the creation of biotechnology and pharmacy facilities, organization of production activities, standardization and certification of production, quality control of biotechnological and pharmaceutical products for the assimilation and use of the principles and rules of good manufacturing practice and further application of the acquired knowledge and skills in the study of general and special technology.
Завдання: integral competence: -Ability to solve complex specialized problems and practical problems characterized by complexity and uncertainty in biotechnology and bioengineering, or in the process of learning that involves the application of theories and methods of biotechnology and bioengineering general competencies: -GC01. Ability to apply knowledge in practical situations professional competencies: -PC03 Ability to analyze regulatory documents to ensure the engineering activities of the biotechnology industry -PC07 Ability to take into account the commercial and economic context in the design of biotechnology products for various purposes (industrial, food, pharmaceutical, agricultural, etc.).
Learning outcomes: COM2. Ability to use a variety of methods, including modern information technologies, for effective communication at professional and social levels. AiB1. Ability to adapt to new situations and make appropriate decisions. AiV 3. The ability to take responsibility for the work performed, to make decisions independently, to achieve the set goal in compliance with the requirements of professional ethics.
Required prior and related subjects: Prerequisites: • Foundations of Labour Protection and Occupational Safety and Health Co-requisites: • Pharmaceutical Chemistry • Processes and Equipment of Biotechnological Industry • Designing and Equipment of Biotechnological Enterprises • Biomonitoring, Biosafety, Biosecurity and Ecological Expertise • Simulation and Scaling of Biotechnological Production in the GMP System • Control Methods in Biotechnology
Summary of the subject: The discipline considers standards as a regulatory basis for product quality management and certification; general requirements for the content, presentation, design of standards and technical conditions; product quality management; ISO international standards for quality management systems; legislative and regulatory framework for the production of medicinal products; The State Pharmacopoeia of Ukraine as the main regulatory document regulating the quality control of medicinal products in Ukraine; good production practice; regulations for the production of medicinal products; product certification.
Опис: Introduction to the course "Regulatory Support of Biotechnology Production" Topic: Standards as a regulatory framework for product quality management and certification. Topic: General requirements for the content, presentation, and design of standards and technical specifications. Topic: Product quality management. Topic: International ISO standards for quality management systems. Topic: Legislative and regulatory framework for the production of medicines. Topic: State Pharmacopoeia of Ukraine. Topic: Good manufacturing practice. Topic: Regulations for the production of medicinal products Topic: Product certification
Assessment methods and criteria: The main methods of knowledge diagnosis are: current (PC) and semester control (SC), which is carried out from educational material, the scope of which is determined by the work program of the discipline for the semester. Current control is carried in order to check the level of assimilation of theoretical and practical knowledge and skills of the student. Semester control is conducted in the form of an exam consisting of a written work and an oral component.
Критерії оцінювання результатів навчання: Semester control is conducted in the form of an examination (EC). Examination control includes a written (60 points) and an oral (10 points) component. The written assignment includes tests/ECEs. The written answer may be supplemented by an oral/written justification of the answer, which allows to assess the student's knowledge of the discipline at the verbal level.
Порядок та критерії виставляння балів та оцінок: 100-88 points - ("excellent") is assigned for a high level of knowledge (some inaccuracies are allowed) of the educational material of the component contained in the main and additional recommended literature sources, the ability to analyze the phenomena studied in their interconnection and development, clearly, concisely, logically, consistently answer the questions posed, the ability to apply theoretical provisions in solving practical problems; 87-71 points - ("good") is assigned for a generally correct understanding of the educational material of the component, including calculations, reasoned answers to the questions posed, which, however, contain certain (insignificant) shortcomings, for the ability to apply theoretical provisions in solving practical problems; 70 - 50 points - ("satisfactory") is assigned for poor knowledge of the educational material of the component, inaccurate or poorly reasoned answers, with a violation of the sequence of presentation, for poor application of theoretical provisions in solving practical problems; 49-26 points - ("not certified" with the possibility of retaking the semester control) is assigned for ignorance of a significant part of the educational material of the component, significant errors in answering questions, inability to apply theoretical provisions in solving practical problems; 25-00
Recommended books: 1. Konstytutsiia Ukrainy. Kodeksy i zakony Ukrainy ([Elektronnyi resurs]. – URL: http://zakon.rada/) 2. Postanovy i Dekrety Kabinetu Ministriv Ukrainy ([Elektronnyi resurs]. – URL: http://zakon.rada/) 3. Natsionalni standarty Ukrainy. 4. Normatyvni akty ministerstv i vidomstv Ukrainy, zareiestrovani ta nezareiestrovani u Miniusti Ukrainy ([Elektronnyi resurs]. – URL: http://zakon.rada/). 5. Other sources of information.
Уніфікований додаток: Lviv Polytechnic National University ensures the realization of the right of persons with disabilities to obtain higher education. Inclusive educational services are provided by the Service of accessibility to learning opportunities "Without restrictions", the purpose of which is to provide permanent individual support for the educational process of students with disabilities and chronic diseases. An important tool for the implementation of the inclusive educational policy at the University is the Program for improving the qualifications of scientific and pedagogical workers and educational and support staff in the field of social inclusion and inclusive education. Contact at: St. Karpinsky, 2/4, 1st floor, room 112 E-mail: nolimits@lpnu.ua Websites: https://lpnu.ua/nolimits https://lpnu.ua/integration
Академічна доброчесність: The policy regarding the academic integrity of the participants of the educational process is formed on the basis of compliance with the principles of academic integrity, taking into account the norms "Regulations on academic integrity at the Lviv Polytechnic National University" (approved by the academic council of the university on June 20, 2017, protocol No. 35).