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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
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Docent, Ph.D., senior researcher, Sofiya Vasylyuk,
Assistant, Ph.D., Natalia Monka
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
- the ability to describe the general requirements for the technology process in accordance with the rules of good manufacturing practice;
- the ability to develop projects involving implementation in enterprises and organizations biotech sector international standards, primarily manufacturing (GMP), clinical (GCP), laboratory (GLP), distribution (GDP), pharmacy (GPP) and other good practices;
- здатність розробляти проекти з урахуванням основ управління біологічним ризиком;
- the ability to develop projects involving implementation in enterprises and organizations biotech sector international standards, primarily manufacturing (GMP), clinical (GCP), laboratory (GLP), distribution (GDP), pharmacy (GPP) and other good practices;
- здатність розробляти проекти з урахуванням основ управління біологічним ризиком;
Required prior and related subjects:
Prerequisites: Simulation and Scaling of Biotechnological Production in the GMP System; Biomonitoring, Biosafety, Biosecurity and Ecoexpert
Co-requisites: Evaluation of the Quality of Biopreparations and Bioproduction
Co-requisites: Evaluation of the Quality of Biopreparations and Bioproduction
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.
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. Надлежащая производственная практика лекарственных средств / Под ред. Н.А.Ляпунова, В.А.Загория, В.П.Георгиевского, Е.П.Безуглой. - К: МОРИОН, 1999. - 896 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. Надлежащая производственная практика лекарственных средств / Под ред. Н.А.Ляпунова, В.А.Загория, В.П.Георгиевского, Е.П.Безуглой. - К: МОРИОН, 1999. - 896 с.
Assessment methods and criteria:
- frontal oral questioning, individual works (20 points);
- final control (80 points, control measure, exam), written-oral form (80 points).
- final control (80 points, control measure, exam), written-oral form (80 points).