Institute for Transfusion Medicine and Gene Therapy

As a drug manufacturer and certified diagnostic laboratory, the Institute for Transfusion Medicine and Gene Therapy (ITG) is subject to a wide range of laws and regulations (AMG, AMWHV, EU GMP, GLP, TFG, FDA regulations for quality systems, ICH Guideline Q10, European Federation for Immunogenetics (EFI), DIN EN ISO 9001). Furthermore, there are regulatory specifications monitored by the authorities for each quality assurance system. A well-structured, effective and cost-efficient quality assurance system is thus indispensable for meeting the increasing quality requirements of the national and international regulations.

The Quality Unit was founded in mid-2014 with the aim to establish a cross-functional unit which coordinates all quality-related processes of the Institute. The Quality Unit implements all relevant quality assurance systems to warrant and continuously improve system quality, process quality, and product quality at the ITG. Since the end of 2016, the portfolio of QU has expanded. The team has been reinforced by a project manager for Quality Management.

The systemic responsibility is fulfilled by correct implementation of the following elements:

• Change management
• GMP and GLP compliance
• Risk and error management
• Documentation
• Document management
• Trainings
• Inspections and audits
• Preparation of site master files (SMF) and reports
• Validations and qualifications

For this, the Quality Unit evaluates the required systems and processes, implements missing structures and defines these using written instructions, monitors the compliance with the specifications and also prepares information and key figures for the Institute’s management.

At the Institute of Transfusion Medicine and Gene Therapy a GMP-compliant temperature monitoring of all storage facilities is established, which allows a 24/7 365-day control and extends over parts of the hospital and the University of Freiburg. In February 2018, more than 80 measuring points are being monitored. In addition, approx. 750 calibrations and qualifications were carried respectively.