Supervisors info:
Ηλίας Κοττέας, Αναπληρωτής Καθηγητής, Iατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Συρίγος, Καθηγητής, Iατρική Σχολή, ΕΚΠΑ
Ανδριαννή Χαρπίδου, Επιστημονικός Συνεργάτης, Iατρική Σχολή, ΕΚΠΑ
Summary:
Quality control of pharmaceutical products is an integral part of the modern pharmaceutical industry, with Good Manufacturing Practices (GMPs) playing a key role. In this thesis, an introduction to quality control of pharmaceuticals was firstly provided, where the concept of quality assurance was approached, as well as the guidelines for drug safety set by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the World Health Organization (WHO). The following section discusses the key features of the development and validation of an analytical method, where quality attributes such as linearity, precision, reproducibility, accuracy, robustness and limits of detection and quantification were analyzed. The evaluation of the relevant characteristics for each method, it is necessary to follow the international guidelines of the International Council for Harmonization of Technical Requirements for Medicinal Products for Human Use [ICH Guidelines Q2(R1) and Q3B(R2)]. In particular, each pharmaceutical form, with this thesis focusing on solid tablets, is prepared differently and the GMPs include the specifications for each form and the guidelines for the whole process. This is followed by an analysis of the tests carried out on the finished products, including homogeneity, solubility and impurity studies. Finally, Process Analytical Techology (PAT), defined as a mechanism for the design, analysis and control of pharmaceutical manufacturing processes through the measurement of critical process parameters (CPPs) that affect critical quality attributes (CQAs), is discussed. The selection of appropriate methods is initially based on the availability of laboratory equipment, the availability of suitably qualified scientific personnel and cost. The main spectroscopic techniques used in PAT are infrared spectroscopy, Raman spectroscopy, Terahertz spectroscopy, X-ray fluorescence spectroscopy (XRF) and, in a few cases, nuclear magnetic resonance, which are non-invasive and non-destructive techniques. Finally, the prospects for the integration of PATs on an industrial scale and studies that have been carried out in this field are discussed.
Keywords:
Quality control, Pharmaceutical industry, Analytical techniques, PAT
