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Good Practice in Pharmacy (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Good Pharmacy Practice, Good Distribution Practice)
Major: Pharmacy, Industrial Pharmacy
Code of Subject: 8.226.00.M.24
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Krychkovska Aelita
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
? must be able to form and lay hands on deep knowledges of principles of pharmaceutical development of medications of different forms of issue, leadthrough of laboratory researches, doklinichnikh tests, clinical tests, registration of medications, requirements, to the mass production, storage, distribution and retail realization of medications, in intercommunication with the requirements of the proper proper practices. The article of research of this discipline is methodology of development of medications and them;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? To point the rules of the proper practice of storage and distribution of medications; to ground principles of pharmaceutical development of medications; to ground principles of achievement of the proper production practice at the production of medications; to ground the role of factors which influence on quality of medications; oriented in normative documents which regulate registration of medications and licensing in Ukraine;
?To determine principles of search of new medications and scientific going near their creation; to describe the system of examination of new medications; to specify information generators about medications; to describe principles of leadingout on pharmaceutical market and use of new medications; to formulate the task of scientific researches in industry of creation of new medications; to work over the chart of pharmacological experiment taking into account ethics, deontologichnikh aspects, basic indexes of informative
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? To point the rules of the proper practice of storage and distribution of medications; to ground principles of pharmaceutical development of medications; to ground principles of achievement of the proper production practice at the production of medications; to ground the role of factors which influence on quality of medications; oriented in normative documents which regulate registration of medications and licensing in Ukraine;
?To determine principles of search of new medications and scientific going near their creation; to describe the system of examination of new medications; to specify information generators about medications; to describe principles of leadingout on pharmaceutical market and use of new medications; to formulate the task of scientific researches in industry of creation of new medications; to work over the chart of pharmacological experiment taking into account ethics, deontologichnikh aspects, basic indexes of informative
Required prior and related subjects:
Prerequisites:
• Organization and economy of farmacii;
• Chemistry and technology of medical substances
Co-requisites:
• An estimation of quality of medical and pharmaceutical technologies (quality of LZ, quality of treatment)
• Application of medications in clinical practice (deep study of farmakoterapya)
• Organization and economy of farmacii;
• Chemistry and technology of medical substances
Co-requisites:
• An estimation of quality of medical and pharmaceutical technologies (quality of LZ, quality of treatment)
• Application of medications in clinical practice (deep study of farmakoterapya)
Summary of the subject:
Conception of providing of quality of medications. Pharmaceutical development. Complex of the proper pharmaceutical practices. Rule the proper laboratory practice. Requirements to researches from pharmaceutical development at creation of different (liquid, soft, hard, transdermal'niy, inhalation) medical forms. Rule the proper doklinical practice. Requirements to the leadthrough of doklinic study in dependence to the type of medication. Proper clinical practice, basic principles and requirements. Clinical tests are in Ukraine. The proper production practice as basis of providing of quality of medications is during a mass production. Rule the proper practice of storage and proper practice of distribution. Proper pharmacy practice. Standards of quality of pharmacy services.
Recommended Books:
1. Методичні вказівки до практичних робіт (практикум) з курсу «Належні практики у фармації (належна виробнича практика, належна клінічна практика, належна лабораторна практика, належна аптечна практика, належна практика дистрибуції)» для студентів вищих медичних і фармацевтичних закладів III-IV рівнів акредитації спеціальності «Фармація» / Гудзь Н.І., Калинюк Т.Г., Білоус С.Б., Сметаніна К.І. – Вінниця: Нова книга, 2013. -368 с.
2. Державна фармакопея України. – Х.: РІРЕГ, 2001. – 556с.; ДФУ. Доповнення 1. - Х.: РІРЕГ, 2004. – 520с.; ДФУ. Доповнення 2. - Х.: РІРЕГ, 2008. – 617с.; ДФУ. Доповнення 3. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2009. – 280с.; ДФУ. Доповнення 4. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2011. – 538с.
3. Етичний кодекс Фармацевтичних працівників України. – Режим доступу: // http://www.moz.gov.ua/ua/portal/Pro_20100528_1.html.
4. Закон України №123/96-ВР від 4.04.1996 р. «Про лікарські засоби», зі змінами.
5. Належні фармацевтичні практики. Офіційний сайт МОЗ України. Режим доступу: http://www.moz.gov.ua
2. Державна фармакопея України. – Х.: РІРЕГ, 2001. – 556с.; ДФУ. Доповнення 1. - Х.: РІРЕГ, 2004. – 520с.; ДФУ. Доповнення 2. - Х.: РІРЕГ, 2008. – 617с.; ДФУ. Доповнення 3. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2009. – 280с.; ДФУ. Доповнення 4. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2011. – 538с.
3. Етичний кодекс Фармацевтичних працівників України. – Режим доступу: // http://www.moz.gov.ua/ua/portal/Pro_20100528_1.html.
4. Закон України №123/96-ВР від 4.04.1996 р. «Про лікарські засоби», зі змінами.
5. Належні фармацевтичні практики. Офіційний сайт МОЗ України. Режим доступу: http://www.moz.gov.ua
Assessment methods and criteria:
• written reports on laboratory work, current control works, individual research assignment - 20 points;
• final control – 80 points (control, exam): written-oral form.
• final control – 80 points (control, exam): written-oral form.
Good Practice in Pharmacy (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Good Pharmacy Practice, Good Distribution Practice)
Major: Pharmacy, Industry Pharrnacy
Code of Subject: 8.226.00.M.24
Credits: 3
Department: Technology of Biologically Active Substances, Pharmacy and Biotechnology
Lecturer: Associate Professor, Ph.D. Krychkovska Aelita
Semester: 4 семестр
Mode of Study: денна
Learning outcomes:
? must be able to form and lay hands on deep knowledges of principles of pharmaceutical development of medications of different forms of issue, leadthrough of laboratory researches, doklinichnikh tests, clinical tests, registration of medications, requirements, to the mass production, storage, distribution and retail realization of medications, in intercommunication with the requirements of the proper proper practices. The article of research of this discipline is methodology of development of medications and them;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? To point the rules of the proper practice of storage and distribution of medications; to ground principles of pharmaceutical development of medications; to ground principles of achievement of the proper production practice at the production of medications; to ground the role of factors which influence on quality of medications; oriented in normative documents which regulate registration of medications and licensing in Ukraine;
?To determine principles of search of new medications and scientific going near their creation; to describe the system of examination of new medications; to specify information generators about medications; to describe principles of leadingout on pharmaceutical market and use of new medications; to formulate the task of scientific researches in industry of creation of new medications; to work over the chart of pharmacological experiment taking into account ethics, deontologichnikh aspects, basic indexes of informative
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? Able to explain conception of providing of quality of medications; to describe going near pharmaceutical development of new medications; to name requirements to the leadthrough of doklinichnikh and clinical researches of medications; to interpret position of the proper production practice;
? To point the rules of the proper practice of storage and distribution of medications; to ground principles of pharmaceutical development of medications; to ground principles of achievement of the proper production practice at the production of medications; to ground the role of factors which influence on quality of medications; oriented in normative documents which regulate registration of medications and licensing in Ukraine;
?To determine principles of search of new medications and scientific going near their creation; to describe the system of examination of new medications; to specify information generators about medications; to describe principles of leadingout on pharmaceutical market and use of new medications; to formulate the task of scientific researches in industry of creation of new medications; to work over the chart of pharmacological experiment taking into account ethics, deontologichnikh aspects, basic indexes of informative
Required prior and related subjects:
Prerequisites:
• Organization and economy of farmacii;
• Chemistry and technology of medical substances
Co-requisites:
• An estimation of quality of medical and pharmaceutical technologies (quality of LZ, quality of treatment)
• Application of medications in clinical practice (deep study of farmakoterapya)
• Organization and economy of farmacii;
• Chemistry and technology of medical substances
Co-requisites:
• An estimation of quality of medical and pharmaceutical technologies (quality of LZ, quality of treatment)
• Application of medications in clinical practice (deep study of farmakoterapya)
Summary of the subject:
Conception of providing of quality of medications. Pharmaceutical development. Complex of the proper pharmaceutical practices. Rule the proper laboratory practice. Requirements to researches from pharmaceutical development at creation of different (liquid, soft, hard, transdermal'niy, inhalation) medical forms. Rule the proper doklinical practice. Requirements to the leadthrough of doklinic study in dependence to the type of medication. Proper clinical practice, basic principles and requirements. Clinical tests are in Ukraine. The proper production practice as basis of providing of quality of medications is during a mass production. Rule the proper practice of storage and proper practice of distribution. Proper pharmacy practice. Standards of quality of pharmacy services.
Recommended Books:
1. Методичні вказівки до практичних робіт (практикум) з курсу «Належні практики у фармації (належна виробнича практика, належна клінічна практика, належна лабораторна практика, належна аптечна практика, належна практика дистрибуції)» для студентів вищих медичних і фармацевтичних закладів III-IV рівнів акредитації спеціальності «Фармація» / Гудзь Н.І., Калинюк Т.Г., Білоус С.Б., Сметаніна К.І. – Вінниця: Нова книга, 2013. -368 с.
2. Державна фармакопея України. – Х.: РІРЕГ, 2001. – 556с.; ДФУ. Доповнення 1. - Х.: РІРЕГ, 2004. – 520с.; ДФУ. Доповнення 2. - Х.: РІРЕГ, 2008. – 617с.; ДФУ. Доповнення 3. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2009. – 280с.; ДФУ. Доповнення 4. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2011. – 538с.
3. Етичний кодекс Фармацевтичних працівників України. – Режим доступу: // http://www.moz.gov.ua/ua/portal/Pro_20100528_1.html.
4. Закон України №123/96-ВР від 4.04.1996 р. «Про лікарські засоби», зі змінами.
5. Належні фармацевтичні практики. Офіційний сайт МОЗ України. Режим доступу: http://www.moz.gov.ua
2. Державна фармакопея України. – Х.: РІРЕГ, 2001. – 556с.; ДФУ. Доповнення 1. - Х.: РІРЕГ, 2004. – 520с.; ДФУ. Доповнення 2. - Х.: РІРЕГ, 2008. – 617с.; ДФУ. Доповнення 3. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2009. – 280с.; ДФУ. Доповнення 4. - Х.: Державне підприємство «Український науковий Фармакопейний центр якості лікарських засобів», 2011. – 538с.
3. Етичний кодекс Фармацевтичних працівників України. – Режим доступу: // http://www.moz.gov.ua/ua/portal/Pro_20100528_1.html.
4. Закон України №123/96-ВР від 4.04.1996 р. «Про лікарські засоби», зі змінами.
5. Належні фармацевтичні практики. Офіційний сайт МОЗ України. Режим доступу: http://www.moz.gov.ua
Assessment methods and criteria:
• written reports on laboratory work, current control works, individual research assignment - 20 points;
• final control – 80 points (control, exam): written-oral form.
• final control – 80 points (control, exam): written-oral form.