Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Assessment of Plants as Raw Materials / Resources for the Production of Medicinal Products in a Globalized Environment

Andres Rodriguez Lüdke (Abschlußjahr: 2018)

Summary
Language: English
This master thesis assesses raw plant materials used in manufacturing medicinal products. To achieve this goal properly, it follows the production chain from cultivation to the entry in the pharmaceutical manufacturing steps, transforming the primary plant material into a medicinal product.
Moving along the production chain mentioned above, this master thesis illustrates step-by-step how more stringent regulations become effective. A particular focus lays on GACP (Good Agricultural Practice) and on its transition from soft law to legally-binding regulations like GMP (Good Manufacturing Practice). Given that the quality aspect is the main focus of GACP and GMP this thesis assesses the quality of herbal substances. Particular focus is set on relevant impurities, impacting negativly the quality of herbal substances.
This thesis primarily focuses on the situation in the European Union and Germany. The interwoven global market, characterized by widely spread supply and production chains, influences these.
Relevant factor are assessed and reflected on in this master thesis with the target of developing improvement suggestions and approaches for possible solutions.
Pages: 73