Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to be modified. Testing protocols for specs have to be properly documented and quality control personnel must be properly trained to ensure quality products. Raw material differences also may result if there is a switch in vendors and/or if quality of raw materials is inconsistent. Management issues may arise if manufacturing is being done by a CMO. These are just a few of the issues that could be of concern.