American Association of Blood Banks (AABB) Case Study
G2MQ was contracted by a medium-sized blood center and stem cell laboratory facility to assist with rectifying post accreditation inspection citations. We set-up systems and processes to meet forthcoming FDA regulations for the manufacture of stem cell products.
Performed high-level analysis of current systems and processes; assisted client in development of a multi-phase roll out corrective action plan; created a comprehensive quality management system integrating requirements of ISO 9000 Quality System, FDA regulations, accreditation agency requirements, and client specific organizational policies and procedures.
Conducted 1 day staff training on Current Good Tissue Practices and Current Good Manufacturing Practices; trained internal QA coordinator to manage and maintain quality systems and processes.
Provided internal audit program to assist client in evaluating efficiency and effectiveness of quality management and operational systems.
Facility re-inspection resulted with commendable practices. Accreditation assessor requested facility’s permission to share best practices and procedures with other institutions.