During transport of pharmaceutical products, external effects can occur, which can lead to massive damage to the product. Pharmaceutical transports have to pass through a qualification process before they can be implemented into routine process. For this purpose, the regulatory requirements from the Arzneimittelbetriebsordnung 2009 have to be followed. In this Bachelor thesis it is explained, which steps are necessary to qualify a thermally insulated container for transport with passive temperature control. The qualification process is also interpreted using a practical example of an in-house transport. The qualification consists three essential steps:
Step 1 - Identification of requirements: In the first step, the existing data are analyzed and the framework conditions of the qualification are defined. The transport route is divided into sections and subjected to a risk analysis. In the practical example, the purpose and scope of the qualification were defined in the document "System Requirement Specification". A process flow chart with a description of the particular process steps has been prepared and the acceptance criteria of the transport have been defined in this step.
Step 2 - Development: In this step the qualification actions are implemented. In course of the design qualification, a suitable transport container is selected. The transport containers undergo an evaluation phase, which can be realized through the test of retention capacity according to DIN 55545-1 and by use of temperature / time profiles. As part of the installation qualification, the actual design of the transport containers is compared with the requirements. The operational qualification is verified by three consecutive qualification runs. In the performance qualification routine transports are provided with data loggers. In this step of the practical example, a risk assessment of the critical parameters was performed in the document "Qualification Protocol" and the validation strategy was defined. Three qualification runs were then carried out for high and low worst case temperature scenarios. The results were summarized in the document "Qualification Report". All qualification runs have met the defined acceptance criteria.
Step 3 - Implementation: For implementation for routine use, all documents have to be adapted and employees have to be trained. This is done via Change Control. The process was also handled in the practical example.
The more risky a transport process is, the more complex qualification steps have to be handled.