14MKKFI - Quality control in pharmaceutical industry

Course specification
Course titleQuality control in pharmaceutical industry
Study programmeChemical engineering
Lecturer (for classes)
Lecturer/Associate (for practice)
Lecturer/Associate (for OTC)
    ConditionОблик условљености
    The goalAcquiring knowledge and skills necessary for work in the control, development and research laboratories of the pharmaceutical industry.
    The outcomeKnowledge 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 of lecturesIntroduction 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 exercisesPreparations 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.
    1. • Pharmacopoea Jugoslavica, Editio quinta (Ph. Jug. V), Belgrade, 2000.
    2. • Modern Pharmaceutics, Fourth Edition, ed. by G.S. Banker and C.T. Rhodes, Drugs and the Pharmaceutical Sciences, vol. 121, Marcel Dekker, Inc, New York-Basel, 2002.
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    Number of hours per week during the semester/trimester/year
    LecturesExercisesOTCStudy and ResearchOther classes
    Methods of teachingLectures (PPT presentation), colloquium (one), homework (one). Experimental exercises.
    Knowledge score (maximum points 100)
    Pre obligationsPointsFinal examPoints
    Activites during lectures20Test paper40
    Practical lessons20Oral examination