This phase of the test involves transfering the design of the assay into manufacturing. This is a huge undertaking as all processes and formulations need to be finalized. Then one has to create manufacturing documents, labels, Saftey Data Sheets, Kit boxes, Calibration kit boxes (if separate), Instructions for Use, packing inserts, etc. ...that are clear and concise and easy to understand for someone who might not be a scientist. While it may seem easy at first, there are lots of pitfalls here too that can catch one off-guard. Here is a list of just a few things to think about:
As you can see there are lots of things to get accomplished in this phase and it's easy to miss something. I have sucessfully transfered over a dozen large and complex assays into manufacturing.