Masterarbeit

Implementation of Regulatory Requirements for Lipid based Excipients - Claims and Reality

Dr. Daniel Zucker (2019)

Summary
Language: English
In this thesis, I present an overview of the pharmaceutical laws and guidelines about excipient information, such as certificates of suitability, investigational medicinal products (IMP) dossiers, and market authorization applications (MAA), which should be provided in regulatory documents. The thesis concentrates on regulatory affairs issues in regards to medicinal products for human use in the European Economic Area (EAA). Furthermore, I discuss practical examples of lipid-based excipients (LBE) in order demonstrate how regulatory issues impact the manufacturers and users of excipients.
Finally, the regulatory challenges for developers and manufacturers of excipients are discussed, and possible solutions are suggested in order to implement the regulatory requirements in a practical industrial operation. As a practical example, the need to implement an excipient master file in Europe is presented and discussed.
Pages: 69,
Annexes: pages: 10