Common use of Master Batch Record Clause in Contracts

Master Batch Record. Cangene will provide the Specifications to Patheon and Patheon will manufacture Product in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the Product, however, Cangene is responsible to review and approve such master batch records prior to the manufacture of the Product. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by Cangene’s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by Cangene’s quality unit prior to implementation unless otherwise agreed to in writing. Quality QG01-05-T001-01 Agreement