Mapping and optimizing the procedure for managing a change in CEP for TSE at a global pharmaceutical company
- At: 2017 FIP Congress in Stockholm (Sweden)
- Type: Poster
- By: INADSSON, Karin (Student, Stockholm, Sweden)
- Co-author(s): Karin Inadsson: Student in Master of Science in Pharmacy at Uppsala University , Stockholm, Sweden
A “Certificate of Suitability” (CEP) for Transmissible Spongiform Encephalopathy (TSE) is a part of the dossier. The CEP is a way to demonstrate TSE compliance for gelatin of animal origin. A change in the CEP has to be managed as a regulatory change. The authorities have different requirements to manage the change, which can complicate.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.