Home/ Majors directory/Industrial Pharmacy/Quality Control of Medicines
Quality Control of Medicines
Major: Industrial Pharmacy
Code of subject: 7.226.02.O.047
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor Bolibrukh Liliia Dmytrivna
Semester: 8 семестр
Mode of study: денна
Завдання: The study of the discipline involves the formation of students' skills:
General competencies:
Ability to know and understand the subject area and understanding of the specialty; ability to learn, perceive the acquired knowledge in the subject area and integrate it with existing knowledge.
Specialized competencies:
Ability to apply knowledge of modern methods of quality control of pharmaceutical products; ability to conduct qualitative and quantitative analysis of raw materials, intermediates and finished pharmaceutical (including veterinary and medicinal and cosmetic) products according to the provided methodology.
Learning outcomes: Ability to apply the requirements of the current legislation of Ukraine on quality control of medicines, knowledge of modern quality control systems of medicines, quality management systems in pharmaceutical plants.
Ability to communicate, including oral and written communication in Ukrainian and foreign languages.
Ability to use a variety of modern methods, in particular, modern information technologies for effective communication at professional and social levels.
Ability to realize the need for lifelong learning in order to deepen acquired and acquire new professional knowledge.
Ability to be responsible for the work performed, to make decisions independently, to achieve the goal in compliance with the requirements of professional ethics.
Required prior and related subjects: Associated and following academic disciplines:
Modeling and design of chemical and pharmaceutical enterprises in the GMP system
Industrial technology of pharmaceutical production
Industrial equipment of chemical and pharmaceutical enterprises
Summary of the subject: Material on the main tasks and functions of the State Inspectorate for Quality Control of Medicinal Products, functions and responsibilities of the quality control department, incoming quality control of medicinal products in pharmacies, organization of quality control of business entities engaged in wholesale trade in medicinal products is presented. The grounds for prohibition (suspension) and withdrawal from circulation of medicinal products in Ukraine, the procedure for prohibition (suspension) and withdrawal from circulation of medicinal products in Ukraine are provided.
Опис: The history of the modern system of quality control of medicines in Ukraine. The concept of Good Pharmaceutical Practices (GXP) and their role in ensuring quality at all stages of the life cycle of medicines. Regulatory framework for quality assurance of medicinal products in Ukraine and the European Union. Validation. Standardization of medicinal products in Ukraine. The State Pharmacopoeia of Ukraine – the main standard of the pharmaceutical industry. Quality criteria for medicines. State quality control of medicinal products. State system of quality assurance of medicinal products. State Service of Ukraine on Medicinal Products, functions and powers. Registration of medicinal products. Licensing of medicinal products in the EU. Pharmacovigilance system in Ukraine. Certification of pharmaceutical products and quality systems in Ukraine.
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 out during lectures and laboratory classes in order to check the level of assimilation of theoretical and practical knowledge and skills of the student. PC is conducted in the form of: performance of control work, written and oral control and protection of laboratory work.
Semester control is carried out in the form of differentiated credit (credit). Differentiated credit is a form of SC of the student's study results exclusively for all types of work provided by the program of the academic discipline.
Критерії оцінювання результатів навчання: Written and oral control - 50 points
Defense of laboratory work - 20 points
Completion of the control work - 30 points
Порядок та критерії виставляння балів та оцінок: 100–88 points – (“excellent”) is 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, and 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, a violation of the sequence of presentation, or 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) are 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, and ignorance of the main fundamental provisions.
Recommended books: 1. Нормативні акти з організації роботи аптечних та хіміко-фармацевтичних підприємств. Т.З. Реалізація та контроль лікарських засобів в Україні.// Тернопіль, Укрмедкнига, 2003 р.
2. Настанова 42-3.1:2004. Настанови з якості. Лікарські засоби. Фармацевтична розробка. - Київ, 2004. – 16 с.
3. Настанова СТ-Н МОЗУ 42-4.0:2010 Лікарські засоби. Належна виробнича практика / М. Ляпунов, О. Безугла, О. Соловйов та ін. – Київ: МОЗ України, 2010. – 169 с.
4. Настанова 42-01-2003 Лікарські засоби. Технологічний процес. Документація. – К.: МОРІОН. – 2003. – 42 с.
5. Державна Фармакопея України. – Х.: РІРЕГ, 2001. – 556 с.; Доповнення 1, 2004. – 520 с.; Доповнення 2, 2008. – 617 с.; Доповнення 3, 2009. – 280 с. ; Доповнення 4, 2011. – 540 c. 3.
6. Закон України «Про лікарські засоби» № 123/96-ВР від 4.04.96.
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