Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implementation of Quality by Design in the Pharmaceutical Development of semisolid topical drug products ***

Dr. Saskia Siewert (Abschlußjahr: 2011)

Language: English

Quality by Design (QbD) summarizes a concept introduced in the ICH Q8 "Guideline on Pharmaceutical Development" and further described in ICH Q9 and Q10. The establishment of quality by design is driven by the understanding that quality cannot be tested into a product. As a consequence the focus of pharmaceutical development activities is shifted from the finished drug product to the manufacturing process and raw materials. The changed focus is aimed to receive a deeper product and process understanding and to identify relationships between the input variables during the manufacturing (e.g. process parameter, material attributes) and the quality of the finished product. Integrated risk analysis tools allow the improved definition of critical attributes and process parameters as well as the better detection of variability sources. Several publications and guidelines describe how to implement QbD and the tools covered by the concept.

In the present master thesis general consideration on the iterative process of adopting QbD in the pharmaceutical development are summarized. Possible steps like the establishment of a target product profile, the creation of knowledge spaces and subsequently design spaces as well as the definition of a control strategy are displayed.

In addition the application of QbD to topical semisolids is discussed representatively for ointments. Semisolids and the biopharmaceutical aspects of topical administration are characterized and unique properties of locally acting ointments are described. On concrete examples it is shown how QbD could be exerted to the development and manufacture of ointments.

Pages: 42