MPRs definition
MPRs means master production and control records maintained by MTH Global relating to the Products as required under the Federal Food, Drug and Cosmetic Act and its implementing regulations (which will include any such documentation that is generated by MTH Global and that (i) defines the manufacturing methods, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of the Products, (ii) any specifications of raw materials, resins and other consumables to be used in the manufacture of the Products, (iii) in process and final the Products sampling standards, and (iv) equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing and the Products packaging and aliquoting procedures).
MPRs means the documentation generated by XOMA that collectively defines the manufacturing methods, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of [*] Drug Substance. The Master Production Records shall also include or incorporate by reference, without limitation, such information as the specifications of raw materials, resins and other consumables to be used in the manufacture of [*] Drug Substance, in process and final [*] Drug Substance sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing and [*] Drug Substance packaging and aliquoting procedures.