22FI31 - Good manufacturing practice in the pharmaceutical industry
| Course specification | ||||
|---|---|---|---|---|
| Course title | Good manufacturing practice in the pharmaceutical industry | |||
| Acronym | 22FI31 | |||
| Study programme | ||||
| Module | ||||
| Lecturer (for classes) | ||||
| Lecturer/Associate (for practice) | ||||
| Lecturer/Associate (for OTC) | ||||
| ESPB | 3.0 | Status | ||
| Condition | Облик условљености | |||
| The goal | The aim of the course is to learn students about the basic principles and practice of quality assurance, quality management and quality control in the pharmaceutical indust | |||
| The outcome | The student acquires all the necessary knowledge to understand and apply good manufacturing practice in all areas of the pharmaceutical industry. for the basic unit operations and to do basic equipment design. | |||
| Contents | ||||
| Contents of lectures | Good manufacturing practice-goals and general ideas. Comparison of standards of good manufacturing practice in the European Union and the United States. Regulations for the production of: drugs, medical devices, active pharmaceutical components and excipients. Good manufacturing practice in production - cleanliness and hygiene of the space. Good manufacturing practice in the production of various forms of drugs. Documentation. Good manufacturing practice and quality control. Process validation. Good manufacturing practice for: packaging, storage and transport. | |||
| Contents of exercises | Exercise. | |||
| Literature | ||||
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| Number of hours per week during the semester/trimester/year | ||||
| Lectures | Exercises | OTC | Study and Research | Other classes |
| 2 | 1 | |||
| Methods of teaching | Lectures, problem solving, lab exercise, consultation. | |||
| Knowledge score (maximum points 100) | ||||
| Pre obligations | Points | Final exam | Points | |
| Activites during lectures | Test paper | 70 | ||
| Practical lessons | 30 | Oral examination | ||
| Projects | ||||
| Colloquia | ||||
| Seminars | ||||