Syllabus
Lectures and seminars
The role of international and national regulatory authorities in ensuring the quality and safety of pharmaceuticals.
Registration of drugs from the viewpoint of pharmaceutical analysis.
Good Manufacturing Practice (GMP) in Pharmaceutical industry and analytical laboratory.
Tasks and activities of the Quality Control (QC), Quality Assurance (QA) in pharmaceutical industry.
The role and activities of a Qualified Person (QP) at the release of drug batches.
Analytical evaluation of biological drugs.
Stationary phases used in separation methods and trends in their development.
Solid-state pharmaceutical analysis (NMR, X-ray diffraction, DSC, TGA).
Modern trends in Pharmaceutical analysis (SFC, sensors, bio-pharmaceuticals)
Bioequivalence studies.
Mass spectrometry in pharmaceutical analysis.
Practical training
Tests for the purity of pharmaceuticals and pharmaceutical excipients using AAS.
Pharmacopoeial evaluation of purified water quality using TOC.
HPLC / UHPLC Method transfer for evaluation of medicinal products.
The use of head-space gas chromatography in the analysis of drugs and biologically active substances.
Quantification and identification of drugs and their metabolites using LC/MS.
Annotation
The issue of ensuring the quality and safety of medicines is a topical task of modern pharmacy worldwide. Pharmaceutical analysis (FA) addresses this area. The attention in the subjects Pharmaceutical Analysis I and II is mainly focused on the pharmacopoeial analysis and analytical evaluation of drugs, especially according to Czech and European Pharmacopoeia.
Subject Advanced Pharmacy Analysis (AFA) follows the theoretical and practical teaching of above-mentioned subjects and offers the students a broadening of knowledge in the field of pharmaceutico-analytical and bioanalytical evaluation of drugs, including familiarization with modern trends in these fields. One of the aims of the PFA course is to bring students closer to the activities aimed at ensuring the quality and safety of medicines in the pharmaceutical industry. This topic will be presented by practitioners who professionally deal with quality control and quality assurance. Teaching will focus not only on theory but also on practical skills.