Infopaket

Regulatory support of biotechnological productions

Обов’язкова дисципліна для ОП

First

2023/2024

7 Semester

5

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).

Full-time form

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.

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.

Lecture, practical classes, independent work

Semester assessment: 1. Module control work 1 - PH 1.1-1.4 - 20 points/10 points 2. Module control work 2 - PH 1.5-1.8 - 20 points/10 points 3. Control work - WP 1.1-2.4 - 30 points/15 points 3. Survey, presentation - WP 2.1-2.4 - 20 points/10 points. 4. Report, abstract - EQ 3.1 - 10 points/5 points Final assessment: in the form of a credit

Ukrainian