Common use of Master Batch Record Clause in Contracts

Master Batch Record. The Client will provide the early development reports and CTM Specifications to Patheon and Patheon will manufacture the CTM in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the CTM, however, the Client is responsible to review and approve such master batch records prior to the manufacture of the CTM. 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 the Client’s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by the Client’s quality unit prior to implementation unless otherwise agreed to in writing.