Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Worldwide Good Distribution Practice (GDP) guideline: a regulatory need and challenge

Dr. Naséra Hammouti (Abschlußjahr: 2023)

Summary
Language: English
Over the last 15 years the distribution of pharmaceuticals increased considerably and became global with medicinal products manufactured on a continent for markets on other continents. In the European Union the distribution of medicinal products for human use is regulated since 2013 by the good distribution practice guideline (GDP). The goal of this work was to evaluate the degree of harmonization at a global scale of the regulatory framework for the distribution of pharmaceuticals based on: (i) the available guidance from the international organization WHO, PIC/S and ICH; (ii) the results provided by a global database tool (Cortellis Regulatory Intelligence™). GDP specific guidelines from the WHO and PIC/S do exist but no ICH guideline. A result for GDP Guidelines were found by 70 countries from the six WHO regions. The establishment of a quality management system with a common defined structure and sections assuring the traceability within the distribution system contribute to harmonization. However, the products in scope the GDP Guidelines varies a lot between the countries and the WHO Regions. Also, a lack of common wording and definition of terms globally has been identified. Considerations are made on how a worldwide GDP Guideline could look like. The establishment of a ICH standard guideline on the global distribution of pharmaceuticals could be a huge contribution to the harmonization process of the regulatory framework in this field.
Pages: 51
Annexes: 5, Pages: 17