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Lecturer(s)
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Papoušková Barbora, RNDr. Ph.D.
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Course content
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Introduction to a pharmaceutical production focused on the technology of production of pharmaceuticals. Analytical and physical methods used in pharmacy (chromatography, titration methods, spectral methods, specific surface area, bulk and tapped density...). Validation and verification of the analytical methods. Stability of drugs. Good laboratory practice, quality assurance department and registration of medicines. Pharmacopoeia, requirements of state authorities.
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Learning activities and teaching methods
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Lecture, Dialogic Lecture (Discussion, Dialog, Brainstorming)
- Attendace
- 52 hours per semester
- Excursion
- 13 hours per semester
- Preparation for the Course Credit
- 26 hours per semester
- Preparation for the Exam
- 29 hours per semester
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Learning outcomes
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The main objective of the course is to familiarize students with the analytical methods ensuring quality, safety and efficacy of drugs that are commonly used in the pharmaceutical industry. Quality requirements of drugs in connection with the guidelines of Good Laboratory Practice and Good Manufacturing Practice are incorporated in the course.
Students will become familiar with the standard procedures of quality assurance, safety and efficacy of drugs. Next, they obtain the necessary information on production processes, quality control and routine analytical methods used in pharmaceutical practice. Also, they get an overview of legislation in the pharmaceutical industry.
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Prerequisites
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The knowledge of basics of general, organic, anorganic, physical, analytical chemistry, biochemistry and instrumental methods is recommended.
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Assessment methods and criteria
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Oral exam
75% attendance in the lecture
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Recommended literature
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Český lékopis - SÚKL.
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European Pharmacopoeia (EP).
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U.S. Pharmacopoeia (USP).
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J. Klimeš. Kontrola léčiv I. a II..
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J.Klimeš. Kontrolně-analytické hodnocení léčiv lékopisnými metodami.
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