Monitoring the Method Transfer Process

Similarly, environmental or seasonal changes may have an impact, where the routine use of local microenvironments during incubation steps has been found to be essential. In such cases, there may be a requirement for using incubators that are capable of maintaining constant ambient temperatures. Such anecdotal issues can be used to develop a checklist that can be used for future method evaluations and/or troubleshooting. 

When issues arise with the performance of the method during the transfer, troubleshooting should be coordinated through both teams (sending and receiving labs). Troubleshooting guidelines are discussed subsequently. 

All of these activities should be defined and mechanisms established to allow the monitoring process to occur smoothly. Some of the details of the monitoring process may not be included in the transfer plan directly, but should be documented as part of meeting minutes or notes. 

In the following sections, important steps in the monitoring process will be discussed in more detail, including evaluation of experiments and their data, impact of experiment failures on timelines, communication of changes in personnel and schedule on either side, and changes in the scope of the agreed-upon transfer work. 

The first experiments may be the most challenging during a method transfer. They can test the effectiveness of the established communication processes and can reveal immediate transfer problems. Data review by the sending lab will be crucial in identifying transfer problems early on. Reduced or increased signal strength, slope changes, and standard curve shifts can indicate suboptimal method performance. 

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