Process Development Run definition
Process Development Run means a Run used to demonstrate the transfer of Sponsor’s then current production process to Fujifilm and/or development at Fujifilm of the process, including a Demonstration Run.
Process Development Run means a Run used to demonstrate the transfer in to Paragon and/or development at Paragon of the Manufacturing Process.
Process Development Run. (or “Demonstration Run”) means a Run used to demonstrate the transfer to Paragon and/or development at Paragon of the Manufacturing Process. A Demonstration Run may be conducted under some or all cGMP conditions, but is conducted by process development personnel and is not considered an Engineering Run or Manufacturing Run. Unless otherwise provided for in the applicable SOW/Project Plan, drug substance (or other product) resulting from a Demonstration Run should not be used for toxicology studies.