Auditing, QP Release, and QP Certification, Chinese Client
Category: QP Certification Services
Based on an ongoing consulting engagement by Cilatus BioPharma Consulting, Cilatus Manufacturing Services was approached by a Chinese Biopharmaceutical Company to provide QP Release and QP Certification services for a biologic investigational product for a European Union clinical trial. Cilatus mapped the entire clinical supply chain with the Chinese client and also recommended a path forward for importation, warehousing, and distribution of clinical supplies in the European Union. Then Cilatus performed the required QP Audits of the manufacturing facilities for drug substance, drug product, and packaging at multiple locations in China. Next, Cilatus performed all required QA batch record reviews and was able to successfully QP release and provid the required QP Declarations for IMPD and CTA filing in the European Union.