Pharmaceutical Enterprises Activities Regulatory

Major: Pharmacy, Industrial Pharmacy
Code of subject: 6.226.02.E.091
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Professor, DSc. Maryna Stasevych
Semester: 5 семестр
Mode of study: денна
Learning outcomes: A student should: - have knowledge of an understanding of production management of pharmaceuticals and basic normative and technical documents; - know the basics of standardization, certification, metrologic control, pharmaceutical licensing of industrial production in terms of good manufacturing practices; - know the requirements of quality management systems for pharmaceutical companies; - issue normative and technical documentation.
Required prior and related subjects: Co-requisites: Management and marketing in pharmacy The organization and economics of pharmacy Quality control of medicines
Summary of the subject: 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. Metrological control of industrial production. Licensing and control of economic activity for the production of medicines. Good manufacturing practice. Regulatory documentation of production company. Technology and technical regulations industrial enterprises.
Assessment methods and criteria: - thematic test control and written individual tasks - 30 points - final control (exam) - 70 points (written-oral form)
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. - 2016. – 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».