Regulatory Support of Pharmaceutical Industries

Major: Industrial Pharmacy
Code of subject: 7.226.02.O.031
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Professor, DSc. Maryna Stasevych
Semester: 5 семестр
Mode of study: денна
Мета вивчення дисципліни: The student's use of the basics of the legislation that regulates the rules for the creation of pharmaceutical production facilities, the implementation of quality control of pharmaceutical products, the organization of production activities, the standardization and certification of production, the assimilation and use of the principles and rules of proper pharmaceutical practice and the further application of the acquired knowledge and skills in the study of general and special technology, completion of all types of practice, completion of course and diploma projects, in future production and practical activities.
Завдання: • FK3 the ability to use regulatory and technical documentation necessary for the implementation of engineering activities in the field of pharmacy and the ability to draw up technical documentation when developing a pharmaceutical production project; • FK9 ability to use a complex of knowledge regarding the principles of implementation of pharmaceutical development, requirements for production, distribution and retail sale and rational use of drugs; • FK15 to have the skills to maintain accounting documentation, coordinate regulatory documents of pharmaceutical industries in accordance with international requirements and principles of good manufacturing practice (GMP), perform validation work and draw up certificates, acts, official memos, etc.
Learning outcomes: As a result of studying the discipline, the student should be able to demonstrate the following learning outcomes: • know the legislative and regulatory and technical documentation for the production of medicinal substances and medicines; • know the classification of the main regulatory documents of pharmaceutical production; • apply legislative and regulatory and technical documentation in the process of production of medicines; • compile some sections of the regulations for pharmaceutical products; • analyze normative documents (standards, technical conditions, regulations). As a result of studying the discipline, the student must be able to demonstrate the following program learning outcomes: • РН1: ЗН 22 Basic knowledge of the main regulatory and legal acts and reference materials, current standards and technical conditions, instructions and other regulatory documents in the field of pharmacy and industrial pharmacy • РН2: ЗН 23 Knowledge of the regulatory framework that regulates the rules of organization and management of the production process of chemical and pharmaceutical products • РН6: АиВ3 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: Management, marketing and pharmaceutical commodity science Organization and economics of pharmacy Co-requisites: Industrial technology of pharmaceutical industries part 1, part 2 Modeling and design of chemical and pharmaceutical enterprises in the GMP system Industrial equipment of chemical and pharmaceutical enterprises Quality control of medicines
Summary of the subject: The material on the requirements of the regulatory and legal regulation of the activities of pharmaceutical enterprises is presented, the regulatory and technical documents regulating the procedure for organizing the production of pharmaceutical products, licensing, standardization, product certification, requirements for the organization of quality management systems at pharmaceutical enterprises, the rules for creating production documentation and maintaining technological process.
Опис: Production management of medicines in Ukraine. Standardization and certification of medical products in Ukraine. The international standards system and quality management in the pharmaceutical industries. Good manufacturing practice. Regulatory documentation of production company. Technology and technical regulations industrial enterprises. Registration of medicines in Ukraine.
Assessment methods and criteria: - thematic test control and written individual tasks - 30 points - final control (exam) - 70 points (written-oral form)
Критерії оцінювання результатів навчання: The maximum score in points is 100 points, of which: - Current control - 30 points - Exam control - 70 points (exam - 60 points, oral component - 10 points)
Порядок та критерії виставляння балів та оцінок: 100–88 points – (“excellent”) awarded for a high level of knowledge (some inaccuracies are allowed) of the educational material of the component contained in the main and additional recommended literary sources, the ability to analyze the phenomena being studied in their interrelationship and development, clearly, succinctly, logically, consistently answer the questions, the ability to apply theoretical provisions when solving practical problems; 87–71 points – (“good”) is awarded 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 when solving practical tasks; 70 – 50 points – (“satisfactory”) awarded for weak knowledge of the component’s educational material, inaccurate or poorly reasoned answers, with a violation of the sequence of presentation, for weak application of theoretical provisions when solving practical problems; 49-26 points - ("not certified" with the possibility of retaking the semester control) is awarded for ignorance of a significant part of the educational material of the component, significant errors in answering questions, inability to apply theoretical provisions when solving practical problems; 25-00 points - ("unsatisfactory" with mandatory re-study) is awarded for ignorance of a significant part of the educational material of the component, significant errors in answering questions, inability to navigate when solving practical problems, ignorance of the main fundamental provisions.
Recommended books: 1. Нормативно-правове регулювання діяльності біотехнологічних і фармацевтичних підприємств. М.В. Стасевич, А.М. Кричковська, Б.П. Громовик, Д.Б. Баранович, О.М. Корнієнко, В.П. Новіков. - Львів: Нова книга. - 2018. – 288с. 2. Державна Фармакопея України / Державне підприємство «Науково-експертний фармакопейний центр» - 2-е вид. - Харків: РІРЕГ, 2016. 3. Настанова СТ-Н МОЗУ 42-4.0:2020 «Лікарські засоби. Належна виробнича практика».
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).