QP Release, Auditing and QP Certification, US Client
Category: QP Certification Services
Cilatus Manufacturing Services was selected by a Boston-based, US Biopharmaceutical Company to provide QP Release and QP Certification services for their clinical-stage lead asset. Cilatus completed all QP Audits of all manufacturing, testing and packaging sites within the supply chain of this small molecule asset. Then Cilatus provided the QP Declarations, which are required for multiple IMPD filings in the European Union. Furthermore, Cilatus performed comprehensive QA reviews of the batch records, which enabled Cilatus to QP Release the client batches as investigational medicinal product following importation into the European Union. In addition, Cilatus provided QA and QP consulting and training to the client in order to create increased awareness of the specific QP requirements within the European Union. Based on the work performed by Cilatus Manufacturing Services for their lead asset, the client decided to extend Cilatus’ QP Release and QP Certification services to multiple products for clinical trials to be executed in the European Union.