As part of #QuestionOfTheMonth, we asked Dr. Rudolph Francke about the most interesting project he has worked on so far as a Senior Consultant and Qualified Person at PharmaKorell. Here is his answer.

“Working at PharmaKorell in the field of pharmaceutical quality management is multifaceted and therefore always very interesting. The collegial environment, consisting of experts from various disciplines, also has a positive impact. This means that colleagues can be efficiently consulted for difficult problems.

The focus of most client projects are the regulatory guidelines and laws dictated by the legislature. For me, a particular client project, which involved a large proportion of professional consultation in addition to ensuring regulatory compliance, was so far the project that I enjoyed the most. This project involved creating a so-called CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia) for a peptide and submitting it to the European Directorate for the Quality of Medicines (EDQM).

The granting of a CEP certifies to the manufacturer that the active substance is sufficiently controlled by the monograph of the Ph. Eur. For the application of a CEP, among other things, the complete validated analytical test methods as well as the complete synthesis path must be submitted.

Assisting the client in compiling the necessary documents for a successful CEP application, ensuring regulatory and technical completeness and accuracy, was a diverse project. The efforts were rewarded when the CEP submission to the EDQM was successfully completed without any objections.”