Master Production Record definition

Master Production Record means the documentation developed by LWI that contains a detailed description of a Process and any other instructions to be followed by LWI in the production of a Product.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Master Production Record or “MPR” means the document, proposed by LONZA and approved by PROTEON, that 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 Record shall also include or incorporate by reference, without limitation, such information as Materials Specifications, 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.

Master Production Record means, with respect to any particular PRODUCT, the formal set of instructions for PRODUCTION of such PRODUCT.

Examples of Master Production Record in a sentence

LONZA will maintain accurate and complete records and samples relating to the manufacture and supply of the Product and conduct of the Process, as necessary to evidence compliance with this Agreement, the Quality Agreement and Applicable Law, including without limitation, the Master Production Record, all Batch Records, LONZA Operating Documents, certificates of analysis, quality control and laboratory testing and other data required by Applicable Laws.
LONZA will use Reasonable Commercial Efforts to manufacture and supply the Product and release to CLIENT the quantities of Product ordered by CLIENT pursuant to Purchase Orders (other than cell banks, which shall be as set forth in an SOW), all in accordance with the terms and conditions of this Agreement, including the Process, Specifications (other than for Engineering Batches), Master Production Record, Quality Agreement, Production Schedule and Applicable Laws.
LONZA will package and label the Product for shipment in containers in accordance with the Process, Specifications, Master Production Record, Quality Agreement and Applicable Laws in effect at the time of performance by LONZA.
Except as otherwise set forth in the Quality Agreement, LONZA will allow representatives of any applicable Regulatory Authority to inspect the relevant parts of the Facility where the manufacture and supply of the Product is carried out and to inspect the Master Production Record, Project Documentation and Batch Records to verify compliance with Applicable Laws, cGMP and other practices or regulations.
For the avoidance of doubt, the Process and the Master Production Record are solely and exclusively owned by CLIENT.

More Definitions of Master Production Record

Master Production Record means a detailed description of a Process and any other instructions to be followed in the production of Product by means of such Process.

Master Production Record or “MPR”. The MBR may be amended from time to time by mutual written agreement of the Parties

Master Production Record means the certain documents approved by NeurogesX that define the manufacturing methods and procedures, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of API.

Master Production Record means the document, proposed by NOVASEP and subsequently approved in writing by CUSTOMER and which specifies the Raw Materials with their quantities and the packaging materials, together with a detailed description of the procedures and precautions required to produce a specified quantity of an intermediate, bulk or finished product as well as the processing instructions, including the in-process controls;

Master Production Record means, with respect to a Product, the documentation developed by LONZA that contains a detailed description of a Process and any other instructions to be followed by LONZA in the production of such Product.

Master Production Record means Inex's complete detailed manufacturing and control instructions and specifications for the manufacture of the Product, as defined by Regulatory Requirements, as amended from time to time by mutual agreement of the Parties. The current Master Production Record is identified as set out in Exhibit 1.1.44.

Master Production Record means the documentation developed jointly by CBSW and Clients that contains a detailed description of the Process, Materials, Chemicals, Equipment, Aids and any other instructions to be followed by CBSW in the production of the Product.