We have established a formal long-term collaboration (including independent arrangements for quality assurance monitoring and audit) with the Australian Red Cross Blood Service (ARCBS) www.arcbs.redcross.org.au. This involves the joint appointments of a quality systems manager (QSM) and a quality systems officer (QSO) to manage the CBCT QS along with a document control function provided through ARCBS. We have a comprehensive QS for ‘routine’ products, such as peripheral blood progenitor cell collection and processing, through to novel experimental products produced for clinical trials.

To date, in peer comparisons, we have found that our QS have met or exceeded those of our local and international collaborators. An extensive documentation system for relevant protocols and procedures within the CBCT has been developed to comply with cGMP requirements. In addition to covering all stages of production, namely collection, processing, storage and release, it also addresses the following elements: equipment (purchase, use, and maintenance); materials (specifications, quarantine, and release); and quality systems (quality control, validation, and document control).

Where our system interacts with hospital infrastructure departments, such as engineering and purchasing, service level agreements (SLA) have been established. We have a formal training and continuing education and competency assessment system for staff, which includes learning modules, training and assessment, and procedural change management. Technical Master Files (TMF) have been produced for autologous blood stem cells, mononuclear cells, dendritic cells, and gene transfer protocols.

The CPC is the most tangible aspect of a CT facility and it must conform to a variety of requirements to meet the demands of GMP. The TGA has specified that apheresis is to be an integral part of the regulated manufacturing environment. The apheresis unit falls within the direct control of the CBCT with a fully-equipped four room apheresis suite.