The transfer of a product to a contract manufacturer can be divided into different phases. Systematic and standardised planning and implementation of the transfer helps prevent errors, repetition and failure. Examples for the individual phases are shown below (see Figure 1).
Figure 1: Examples of technology transfer phases
Specific information is required to ensure that the contract manufacturer can properly evaluate the project request. The factors listed in Figure 2 are examples of factors that are considered during the evaluation.
A comparison of the processes and technologies used at the two manufacturing locations is vital for the evaluation of the potential risks of the transfer project. The individual process steps of the sending unit and the contract manufacturer are compared. Differences in machines, systems and batch sizes are identified. These differences are an indication of the changes required for an authorisation adjustment strategy.
The initial evaluation is used to create a project recommendation that is then used as a proposal for implementing the transfer project from the viewpoint of the contract manufacturer. This includes assessment aspects (Figure 17.A-12) and a rough outline of the schedule and content of the project. It is important that the content, scope and responsibilities in the transfer project are clearly specified. If necessary, the contract giver can also propose some concrete specifications for the project. Initial potential risks (e.g. for the target deadlines) can be described and possible measures identified.
After consultation, a master transfer plan for the project can be created or be defined a priori by the contract giver as a guideline. A master transfer plan usually contains:
After the project proposal has been reviewed and evaluated by the contract giver, a decision is made on whether to proceed with the project. The project can also start if the master transfer plan is approved.
Good project management is vital to the success of a transfer project. Detailed documentation of the product transfer is also very important. This is an important aspect of the knowledge transfer on the one hand, and it is required for the change notification of the contract manufacturer (variation to a marketing authorisation) on the other, or for the inspection carried out in the case of such a change notification. The acceptance criteria for a successful product transfer are specified in the transfer plan. If a master transfer plan is available, the requirements and contents of this master plan are described in greater detail in the transfer plan. It contains the planned and implemented steps for the transfer. Figure 3 contains a list of components that should be included in a transfer plan.
Figure 3 Standard content of any technology transfer plan
It is important that the analytical transfer is given top priority to facilitate the evaluation of the production transfer steps using methods that have been successfully transferred. As a rule, this improves the ability to respond to changes or challenges in a flexible manner when it is possible to carry out the analysis of samples directly on site. In the case of multi-purpose facilities, the question of cleaning and cleaning validation must also be dealt with at an early phase of the project to reduce risks to the schedule. The bilateral approval of the transfer plan reflects mutual expectations and represents the beginning of the active transfer phase.
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A Successful Concept for Technology Transfer in Drug Manufacturing
Christian Gausepohl, PhD
Rottendorf Pharma GmbH, Germany