Good Practices in Biotechnology (Good Manufacturing Practice, Good Technology Practice, Good Laboratory Practice, Good Distribution Practice)

Major: Biotechnology and Bioengineering
Code of subject: 8.162.00.M.24
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Ph.D., Associate Professor Petrina Romana, Ph.D., assistant Monka Natalia
Semester: 4 семестр
Mode of study: денна
Learning outcomes: • Knowledge and understanding of the philosophical methodology of scientific knowledge, psychological and pedagogical aspects of professional and scientific activities, own scientific worldview and moral and cultural values. • Combine theory and practice, as well as make decisions and develop a strategy for solving scientific and applied problems, taking into account universal values, social, state and industrial interests. • Work effectively both individually and as a team.
Required prior and related subjects: prerequisites: Planning and organization of scientific research and statistical processing of results; Academic entrepreneurship co-requisites: Quality assessment of biological products and biological products
Summary of the subject: Modern biotechnology and issues of biosafety. Trends of development of regulation in the field of quality medicines. Good practices as assurance quality biotechnology products pharmaceutical and medical appointment. Management of biological risks. Laboratory biosecurity as addition laboratory biosafety. The approach to the management of biological risks. Combating biological risks. Program of laboratory insecurity. Personnel Training. Good practice in the pharmaceutical biotechnology (Good laboratory practice, good clinical practice, good manufacturing practice, good practice of storage, good distribution practice, good pharmacy practice, good practice of pharmacovigilance). Good practice cultivation and harvesting of raw materials of vegetable origin as the first stage production of herbal medicines. Integrated logistics "cold chain" of biotech drugs.
Assessment methods and criteria: - frontal oral questioning, individual works (20 points); - final control (80 points, control measure, exam), written-oral form (80 points).
Recommended books: 1. Левашова И.Г. Надлежащие практики в фармации: учебник / И.Г. Левашова, А.Н. Мурашко, Ю.В. Подпружников. – К.: МОРИОН, 2006. – 256 с 2. Належні практики у фармації: практикум для студ. вищих мед. навч. закладів / Гудзь Н.І., Калинюк Т.Г., Білоус С.Б., Сметаніна К.І.; за ред. Т.Г. Калинюка. - Вінниця: Нова книга, 2013. -368 с. 3. Правила надлежащей производственной практики (GMP) евразийского экономического союза. Версия 4.0 от 20.02.2015. 4. Настанова Лікарські засоби дослідження біоеквівалентності. СТ-Н МОЗУ 42-7.2:2018 Київ Міністерство охорони здоров'я України 2018.