Common use of Master Batch Packaging Records Clause in Contracts

Master Batch Packaging Records. The Client will provide Patheon with the Specifications for all packaging components. Patheon will create, control, issue, and execute in accordance with the master batch packaging record and the Specifications. Patheon will not make changes to master batch packaging 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 agreed to in writing. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.