Master Manufacturing Document Clause Samples
The Master Manufacturing Document clause defines the comprehensive set of instructions, specifications, and procedures required for the consistent production of a product. It typically outlines the materials, equipment, processes, and quality control measures that must be followed during manufacturing. By establishing a standardized reference, this clause ensures product uniformity, regulatory compliance, and minimizes the risk of errors or deviations in the manufacturing process.
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Master Manufacturing Document. The master manufacturing document specifies the Manufacturing Process and Additional Materials used to Manufacture a specific Bulk Product (“Master Manufacturing Document”). Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain the Master Manufacturing Documents, and Strakan shall supply such Master Manufacturing Documents to Aptalis. Strakan shall notify Aptalis in accordance with the provisions of Section 17.1 of the License Agreement and Aptalis shall approve, in writing, all modifications to the Master Manufacturing Document. Aptalis, with the assistance of Strakan, shall ensure that those documents are consistent with the Marketing Authorization file of the relevant Product. Strakan shall provide Aptalis with copies of all revised Master Manufacturing Documents on a timely basis. Aptalis shall retain a copy of the Master Manufacturing Documents.
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.
Master Manufacturing Document. The Master Manufacturing Document specifies the manufacturing process and Materials used to manufacture a specific Bulk Product. Axcan, with the assistance of Paddock, has the responsibility to assure that those documents are consistent with the Product Marketing Authorization. The Master Manufacturing Document will be developed by Paddock and must be approved within 5 business days by Axcan prior to its use. Original Master Manufacturing Documents will be maintained on-site by Paddock and remain available for inspection and review by Axcan and/or its agents. Paddock shall provide copies of all revised Master Manufacturing Documents to Axcan on a timely basis. Axcan will retain a copy of the Original Master Manufacturing Document in its file.