Company Situation
The Client is an American based company specialized in the collection, processing, and donor-recipient matching of blood products in USA and also in supply chain of cell and gene therapy. The client collects from hospitals and blood centers, blood, somatic cell, and cord blood products for both therapeutic and investigational use worldwide. The client implemented an extensive quality audit program to check and monitor the quality of blood products they collect and needed additional qualified GCTP auditors to cover 35 audits in USA.
GRP Solution
GRP brings decades of experience in quality auditing, including GCTP audits, for companies in USA, Europe, Japan, China, Brazil and Mexico and across the globe as well. GRP’s certified biomedical auditors were able to cover 35 GCTP audits for client withing 5 months.
GRP auditors performed GCTP audits to Apheresis centers and centers for blood and blood derivative products according to FDA regulations 21 CFR 1271, 21 CFR 211, 21 CFR 312, 21 CFR 11, 21 CFR 606, 21 CFR 607, 21 CFR 610 and also according to requirements of EU Commission Directive 2006/17/EC and International blood product standards: EU Commission Directives 2002/98/EC, 2004/33/EC.
