Master Production and Control Record definition
Master Production and Control Record or “Master Batch Record” shall mean a written description of the procedure to be followed for processing a batch of Product including but not limited to a complete list of all active and inactive ingredients, components, weights and measures, descriptions of drug product containers, closures, packaging materials, and labeling and complete specifications for each, within the meaning of 21 CFR part 211.186, or its successor as in effect from time to time.
Master Production and Control Record or "MASTER BATCH RECORD" means a written description of the procedure to be followed for processing a batch of Product including but not limited to a complete list of all components, weights and measures, descriptions of Product containers, closures, packaging materials, and labeling and specifications as required by a Project Summary.
Master Production and Control Record. (“MPR”) means the records and data to be generated in the manufacturing and testing of Bulk Drug Substance by Manufacturer to demonstrate that all applicable Standard Operating Procedures and methods have been followed as specified in Exhibit A. MPR need not include the general operating procedures and related data of Manufacturer and which are produced in connection with its general operations.
Examples of Master Production and Control Record in a sentence
All such items purchased by CBL for purposes hereof shall meet the applicable Specifications therefor as set forth on Exhibit A and the Master Production and Control Record.
Subject to the terms and conditions of this Agreement, CBL agrees to process the Product in accordance with a Master Production and Control Record approved in writing by TKT.
CBL further agrees that any substantive changes to the Master Production and Control Record and the process must receive written approval of TKT prior to implementation, provided, however, that any approvals to be delivered by TKT shall not be unreasonably withheld and the parties shall cooperate and act reasonably and in good faith in connection with their respective activities under this Section.