Good Manufacturing Practice (ZFTK_039)
About Study Course
Objective
1. To promote the acquisition of knowledge and forming of understanding of the nature of good manufacturing practice and the importance of requirements in the manufacture of high-quality medicinal products.
2. To promote the acquisition of practical skills for the preparation of information materials for introductory instruction and training on good manufacturing practice.
Prerequisites
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, English.
Learning outcomes
The student gains knowledge that will enable them to understand: GMP guidelines for medicinal products; quality systems applied in the pharmaceutical industry; quality requirements for manufacturing processes in both small-scale and industrial-scale production of pharmaceutical products, including standard operating procedures (SOPs) and monitoring standards required to achieve appropriate quality levels; the relative importance of quality control testing and manufacturing monitoring in ensuring product quality; manufacturing process validation, the role and responsibilities of the qualified person.
As a result of completing the study course, students will be able to assess the influence of manufacturing and storage conditions on the quality of medicinal products, to develop and validate analytical methods for assessing the quality of active substances, excipients, materials, intermediates and final products (finished dosage forms) in accordance with the European Pharmacopoeia, to standardise finished dosage forms, prepare documentation in accordance with GMP and EU guidelines for medicinal products, depending on market requirements, ensure the establishment of a quality control system in a pharmaceutical company, manage the quality control system in a pharmaceutical company, perform batch quality testing and prepare documentation for batch release, develop regulatory and recording documentation for the manufacture of medicinal products.
Ability to organise and ensure GMP-compliant manufacturing of medicinal products; ability to assess risks in the manufacturing of medicinal products and to follow procedures within the scope of personal competence; ability to understand the role of different analytical methods and apply them to the analysis of pharmaceutical products; ability to understand the relative importance of quality control testing and manufacturing monitoring in ensuring product quality.
