GDP-Compliance

To ensure GDP-compliant transports, our quality management system includes GDP-based risk management. Based on a risk analysis in the sense of an FMEA, we verified the transport process and considered all relevant influencing factors. In this way, we can ensure product-specific temperature control along the entire cold chain as well as the monitoring of all critical parameters in real time. This enables us to intervene at short notice in the event of deviations from the target process. The required timely documentation is ensured throughout the entire transport process.

In order to fully meet all requirements, we only use qualified personnel and equipment. Documented training plans determine our training system, in which all employees are integrated. Each employee is trained in GDP regulations at least twice a year by our external Qualified Person (QP) and is only qualified if they pass the exam. All vehicles used are qualified by ATP certificate, calibration and cleaning. The redundant temperature recording systems for transport are checked annually by calibrated measuring instruments and documented as well as regular cleaning. To check the vehicles, we regularly carry out vehicle inspections and document them also.

Clearly formulated SOPs steer our processes and are available to every employee at any time. Among other things, this includes our CAPA/deviation management. Our deviation management is characterized by proactive action, as all deviations from the standard process are documented, checked and evaluated. Every change to a process is documented in our Change Control System.

The continuous execution of self-inspections, in cooperation with our QP, serves to check and improve our process quality as well as to verify compliance with the principles and guidelines of GDP. Furthermore, we are regularly audited by our customers, work with the corresponding protocols/audit reports and in turn carry out audits of our subcontractors ourselves. All service providers are selected, evaluated and managed according to the requirements. Subcontractors are checked on the basis of self-assessment forms and on-site audits. Only qualified subcontractors are used for LIFE LOGISTICS FREIGHT GmbH. If a service provider does not provide GDP-compliant services, it will be recorded on our blacklist and will no longer be used. Only in this way can we ensure that we achieve our own goals.