14MKKFI - Quality control in pharmaceutical industry
| Course specification | ||||
|---|---|---|---|---|
| Course title | Quality control in pharmaceutical industry | |||
| Acronym | 14MKKFI | |||
| Study programme | Chemical engineering | |||
| Module | ||||
| Lecturer (for classes) | ||||
| Lecturer/Associate (for practice) | ||||
| Lecturer/Associate (for OTC) | ||||
| ESPB | 4.0 | Status | ||
| Condition | Облик условљености | |||
| The goal | Acquiring knowledge and skills necessary for work in the control, development and research laboratories of the pharmaceutical industry. | |||
| The outcome | Knowledge of the principles of good manufacturing practice (GMP) and Good Control Laboratory Practice (GCLP). Acquired knowledge and skills in the field of quality control of raw materials, finished products and packaging in the pharmaceutical industry. Ability to solve practical problems, from the choice of appropriate analytical methods, planning and conducting the experiment, the processing, interpretation and discussion of the results obtained. | |||
| Contents | ||||
| Contents of lectures | Introduction to quality control in the pharmaceutical industry. Principles of good manufacturing practice (GMP) and Good Control Laboratory Practice (GCLP). Quality assurance (QA). Legislation. Pharmacopoeia. Quality control of raw materials. Sampling. Determining the physical properties of herbal drugs. Identification of plant drugs. The degree of purity, alcality, acidity, content of chloride and heavy metals. Limit tests. Determination of characteristic constants. Testing of raw materials of animal origin. Microbiological control. Quality control semiproducts. Determination of physical parameters. Solubility and decomposition. Quality control of final products. Pharmaceutical-technological procedures. Biological tests. Testing of solutions, preparations dosing in drops, injections and infusions, suspensions and emulsions, medicinal ointments and suppositories, tablets and capsules. Quality control of packaging. Types of materials used. Containers. Identification of the standards. Glass. Aluminum tubes. Internal protection. | |||
| Contents of exercises | Preparations for the analysis and the analysis of selected pharmaceutical preparations according to the monographs of the pharmacopoeia Ph. Jug. V. Presentation and discussion of the results obtained. | |||
| Literature | ||||
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| Number of hours per week during the semester/trimester/year | ||||
| Lectures | Exercises | OTC | Study and Research | Other classes |
| 2 | 2 | |||
| Methods of teaching | Lectures (PPT presentation), colloquium (one), homework (one). Experimental exercises. | |||
| Knowledge score (maximum points 100) | ||||
| Pre obligations | Points | Final exam | Points | |
| Activites during lectures | 20 | Test paper | 40 | |
| Practical lessons | 20 | Oral examination | ||
| Projects | ||||
| Colloquia | 20 | |||
| Seminars | ||||