Master Manufacturing Record definition

Master Manufacturing Record means for each Program the mutually agreed document which sets out in detail the master production instructions for the Manufacturing Process, as such instructions are defined in sections 6.4 and 6.5 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors Part II: Basic Requirements for Active Substances Used as Starting Materials.

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Master Manufacturing Record means the compilation of records containing the procedures and Specifications for manufacturing a Finished Product A Master Manufacturing Record may be prepared as a single document or file or may be prepared using an index system that specifies the location and identity of individual files, records, or documents that make up the Master Manufacturing Record. Packaging means a pack, box, carton, container or wrapping (including film), in which a Finished Product is offered for sale, sold or delivered. Pest means any objectionable insect or other animal including birds, rodents, flies, and beetles. Physical Plant means all or part of the building or facility used for cc in connection with the manufacturing, packaging, labeling, or holding of a Production Material or Finished Product. Physical Plant means the same thing as “Approved Manufacturing Location” as used in the Agreement.

Master Manufacturing Record means, for each Project, the template document, proposed by Paragon and approved by Client, that defines the final and complete manufacturing methods, test methods, Product Specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of Product. Batch Documentation shall be prepared based on the Master Manufacturing Record. The Master Manufacturing Record shall also include or incorporate by reference, without limitation, such information as Materials Specifications, in process and final Product sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing.

Examples of Master Manufacturing Record in a sentence

• In addition, Paragon shall provide Client with such information as is reasonably requested in writing by Client relating to the Manufacturing Process, the Master Manufacturing Record, Paragon services performed under this Agreement or other Product-related documentation.

• For each Project, Client has (or will have) the right, power and authority to supply to Paragon or allow Paragon the use of, for purposes of the activities contemplated by this Agreement, the applicable Cell Line, Master Cell Bank, Working Cell Bank, Client Confidential Information (including, without limitation, any portion of the Master Manufacturing Record and/or Manufacturing Process supplied by Client to Paragon), and any other information or materials supplied by Client to Paragon.

• Paragon, or a designated Qualified Subcontractor, shall perform such testing on Batches as set forth in the applicable Master Manufacturing Record, or as otherwise mutually agreed in writing by Paragon and Client.

• In addition, Paragon shall provide Client with such information for each Project as is reasonably requested in writing by Client relating to the Manufacturing Process, the Master Manufacturing Record, Paragon services performed under this Agreement or other Product-related documentation.

• Such record shall include complete information relating to the manufacture and control of the Batch and accurately follows the appropriate Master Manufacturing Record and each step taken in the manufacture of the Batch.

• You shall prepare a Master Manufacturing Record for each Finished Product and obtain Customer’s approval.

• The Parties shall mutually identify and Paragon shall retain (until Client Approval pursuant to Section 5.2) certain reserve samples of all Raw Materials, intermediate manufacture samples, and Product generated in the manufacture of Production Batches as set forth in the applicable Materials Specifications, the applicable standard operating procedures, the Master Manufacturing Record or as otherwise agreed in writing by Paragon and Client as provided in the Quality Agreement.

• Paragon shall provide sufficient services and capacity to manufacture Product for Client in accordance with the Project Plan and the Master Manufacturing Record.

• The information in the Master Manufacturing Record shall be based upon defined Finished Product development inputs from Customer and manufacturing scale-up processes.

• The Parties agree that Paragon, in discussion with Client, will organize the scheduling of Production Runs to maximize Paragon’s operational schedule, including scheduling the Runs so as to constitute a campaign of two or more Runs, occurring in sequence, and without planned interruption for suite changeover or modifications to the Master Manufacturing Record, provided that such scheduling shall be subject to suite availability and Paragon’s other scheduling needs.

More Definitions of Master Manufacturing Record

Master Manufacturing Record means, for each Project, the template document proposed by Paragon and approved by Client that defines the final and complete manufacturing methods, test methods, materials, and other procedures, directions and controls associated with the manufacture and testing of Product. Batch Documentation shall be prepared based on the Master Manufacturing Record. The Master Manufacturing Record shall also include or incorporate by reference, without limitation, such information as Materials Specifications, in process and final Product sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing.