Regulatory support of biotechnological productions
Course: Biotechnology (Bachelor) FULL-TIME
Structural unit: Biology And Medicine Institute Science Educational Center
Title
Regulatory support of biotechnological productions
Code
Module type
Обов’язкова дисципліна для ОП
Educational cycle
First
Year of study when the component is delivered
2021/2022
Semester/trimester when the component is delivered
7 Semester
Number of ECTS credits allocated
5
Learning outcomes
PR04. Be able to apply the provisions of regulations governing the certification of products, certification of production, requirements for the organization of quality management systems in enterprises, rules for technical documentation and technological process, based on knowledge gained during practical training. PR05. Be able to analyze normative documents (state and industry standards, technical conditions, guidelines, etc.), compile separate sections of technological and analytical documentation on. Biotechnological products for various purposes; analyze technological situations, choose rational technological solutions. PR13. Be able to carry out a feasibility study for the production of biotechnological products for various purposes (determination of the need for the target product and calculation of production capacity).
Form of study
Full-time form
Prerequisites and co-requisites
1. Successful mastering of the courses "Fundamentals of Biotechnology", "Biosafety in Biotechnology".
2. Be able to independently apply knowledge of molecular biology, biotechnology, pharmaceuticals and other disciplines, perform laboratory and practical work, work with scientific and methodological literature.
3. Have basic skills in working with materials and equipment used in biological and biotechnological laboratories.
Course content
The discipline is designed to provide theoretical knowledge and practical skills on the basics of legislation, analysis and application of regulations and provisions of regulatory and technical documents (state and industry standards, specifications, guidelines, etc.) governing the certification of product certification, production certification, requirements for organization of quality management systems at enterprises, rules of technical documentation and technological process, based on the knowledge gained during practical training.
Recommended or required reading and other learning resources/tools
1. Law of Ukraine "On Standardization" 1315-VII, version of 03.07.2020, "On technical regulations and conformity assessment" of 15.01.2015 № 124-VIII.
3. State Pharmacopoeia of Ukraine / State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines", 2nd ed. - Kharkiv: 2014.
4. ST-N MOZU 42-4.0: 2016. Instructions for medicines. Good manufacturing practice.
5. DSTU: 3803-98 Biotechnology. Terms and definitions. , ISO 9000-2015 Quality management systems. Basic provisions and vocabulary., ISO 9001 - 2015 Quality management systems. Requirements.
9. Normative support of biotechnological productions: Quality management and safety of biotechnological products: Textbook / T.F. Kozlovskaya, OV Новохатько, О.О. Никифорова. - Kremenchuk: KrNU Publishing House - 2017. - 146 p.
Planned learning activities and teaching methods
Lecture, practical classes, independent work
Assessment methods and criteria
Semester assessment:
1. Modular test 1 - PH 1.1-1.6 - 20 points / 10 points.
2. Modular test work 2 - pH 1.7, 1.8 - 20 points / 10 points.
3. Reports on practical classes - RN 2.1-3.1 - 20 points / 10 points.
4. Survey, abstract - RN 2.1-3.1 - 20 points / 10 points.
5. Test work - pH 2.1, 2.2, 2.4, 3.1 - 20 points / 10 points.
Final assessment: in the form of a credit
Language of instruction
Ukrainian
Lecturers
This discipline is taught by the following teachers
Departments
The following departments are involved in teaching the above discipline