Infopaket

Regulatory support of biotechnological productions

Обов’язкова дисципліна для ОП

First

2025/2026

7 Semester

5

PR04. Be able to apply the provisions of regulatory documents that regulate the procedure for product certification, production certification, requirements for the organization of quality management systems at enterprises, rules for drawing up technical documentation and conducting a technological process, based on the knowledge obtained during practical training. PR05. Be able to analyze regulatory documents (state and industry standards, technical conditions, guidelines, etc.), compile separate sections of technological and analytical documentation for biotechnological products for various purposes; analyze technological situations, choose rational technological solutions. PR22. Be able to take into account social, environmental, ethical, economic aspects, requirements for labor protection, industrial sanitation and fire safety when forming technical solutions. Be able to use various types and forms of physical activity for active recreation and leading a healthy lifestyle.

Full-time form

1. Successful completion of the courses "Selected sections of labor law and fundamentals of entrepreneurial activity", "Processes and devices of biotechnological production". 2. Ability to independently apply knowledge of the discipline studied in previous courses to solve specific scientific and practical problems; be able to perform laboratory and practical work, work with scientific and scientific and methodological literature. 3. Possess basic skills in working with materials and equipment used in biological and biotechnological laboratories.

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.

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.

Lectures, practical classes, independent work

Semester assessment: 1. Module control work 1 - 20 points/10 points 2. Module control work 2 - 20 points/10 points 3. Control work - 30 points/15 points 3. Survey, presentation - 20 points/10 points. 4. Report, abstract - 10 points/5 points Final assessment: in the form of a credit

Ukrainian