During routine commercial manufacturing, critical parameters are monitored and trended to ensure that the process is still
operating in a valid manner. Reprocessing or rework is allowed at this stage if such processes are being validated under protocol
or if such processes have already been validated. Reprocessing or rework requires approval of the sponsor.
ConclusionImplementation of this procedure for process development and transfer enables Diosynth and its customers to use a common language
to manage expectations for contracted work.
References1 Diosynth Standard Operating Procedure SOP#80GN1327: Evaluation, Development and Execution of Manufacturing Processes at Diosynth