Master Manufacturing Document. The master manufacturing document specifies the manufacturing process and Materials used to manufacture a specific Bulk Product (“Master Manufacturing Document”). UMAN shall develop and maintain the Master Manufacturing Document that must be approved in a timely manner by CLIENT prior to its use. CLIENT, with the assistance of UMAN, shall ensure that those documents are consistent with the regulatory applications of the relevant Product. Original Master Manufacturing Documents shall be maintained on-site by UMAN and remain available for inspection and review by CLIENT. UMAN shall provide CLIENT with copies of all revised Master Manufacturing Documents on a timely basis. CLIENT shall retain a copy of the Master Manufacturing Documents.
Appears in 2 contracts
Sources: Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.), Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.)