GDP-Compliant Transportation of Pharmaceuticals
Pharmaceutical Logistics – Get GDP Into Motion
Transco also carried out a comprehensive risk analysis and devised worst case scenarios and intervention plans for particular routes based on this. Implementation of the project was broken down into two sub-areas. One team dealt with the technical equipment, concerning itself with the definition and selection of equipment and ensuring that the essential trailer components such as refrigeration units, the ventilation system and the refrigerated trailer itself work together perfectly. A second team designed the supply chain processes, built in the necessary IT systems and carried out the vehicle qualification. Staff training was provided by trainers from an external service provider.
At the end of 2012 a practical test was undertaken successfully. After successfully passing the audit, Transco was awarded a GDP certificate by TÜV Rheinland — demonstrably becoming the first pharmaceutical logistics company in Germany to do so. Exactly one year after the initial certification, the company successfully passed the testing institutes re-audit in August 2015 with flying colours.
As part of its quality management system Transco is gradually incorporating its subcontractors into its GDP qualification. These measures are being driven by the management and the Quality Management Officer (QMB) and are supported by an external Qualified Person (QP).
Three stages to become a subcontractor
In the first stage potential transport service providers are selected based on years of experience and on-site visits, including a tour of the company and talks. If they pass this pre-selection phase, potential candidates, who could work as subcontractors, complete a comprehensive self-evaluation questionnaire on GDP compliance. The results of this “self-audit” are taken into account in the subsequent evaluation by Transco, which also includes drawing up a blacklist of unsuitable companies which receive a negative evaluation. The final stage is the on-site subcontractor audit, including a point-scoring system and the final conclusion: “Is the service provider GDP-compliant — yes or no?”.
If they are found to be compliant, the relevant subcontractor is incorporated into the GDP training system and, following completion of staff training, is “approved” to undertake the transportation of pharmaceuticals on behalf of Transco. The long-term re-audit process includes an annual supplier evaluation in which the German company evaluates the performance and quality of the subcontractor.