Quality Control of Medicines

Major: Pharmaceuticals technologies
Code of subject: 7.226.01.E.34
Credits: 3.00
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Bolibrukh Lilia Dmytrivna
Semester: 2 семестр
Mode of study: денна
Learning outcomes: • to know modern methods of quality control of pharmaceutical products; • to know the procedure of registration of drugs, a system of good manufacturing practice, good laboratory practice system, pharmaceutical marketing basics, fundamentals of international business activity of enterprises; • to be able to determine the basic elements of quality assurance in the production and use of organizational and technical measures for its implementation; • to know the requirements of current legislation of Ukraine on drug quality control at the phases of drugs production, preclinical and clinical testing, registration, re-registration of medicines, transportation, storage and sale.
Required prior and related subjects: Prerequisites: • Pharmaceutical Chemistry • Organization and economy of pharmacy Co-requisites: • Economics of chemical-pharmaceutical enterprises
Summary of the subject: Regulations about the state inspectorate for quality control of medicines. Regulations on the quality control department of companies that manufacture treatments. The functions of quality control department. Quality indicators that are controlled to obtain conclusion concerning of drug quality. Procedure for quality control of drugs in the wholesale and retail trade. The order of prohibition (suspension) and removal from circulation of drugs in Ukraine. The rules of disposal and destruction of defective medicines.
Assessment methods and criteria: • written reports from laboratory work, oral questioning, control work - 40 points; • final control - 60 points (control, exam): written-oral form.
Recommended books: 1. Щепін О.П. Контроль якості лікарських засобів. Довідник // М., Медицина 1986 р. 2. Нормативні акти з організації роботи аптечних та хіміко-фармацевтичних підприємств. Т.З. Реалізація та контроль лікарських засобів в Україні.// Тернопіль, Укрмедкнига, 2003 р. 3. Належна виробнича практика лікарських засобів. Під редакцією Ляпунова, Київ,«Морріон», 1999 р.