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 otherwise agreed to in writing.
Appears in 2 contracts
Samples: Supply Agreement (Relypsa Inc), Supply Agreement (Relypsa Inc)
Master Batch Packaging Records. The client Client will provide Patheon with approve 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 before Master revisions) must be reviewed and approved by the Client’s quality unit prior to before implementation unless otherwise agreed to in writing.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC)
Master Batch Packaging Records. The client 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 Master revisions) must be reviewed and approved by the Client’s quality unit Client prior to implementation unless otherwise agreed to in writing.
Appears in 1 contract
Master Batch Packaging Records. The client Client will provide give 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 unitunit prior to implementation. Any changes made to issued batch records (prior to master before Master revisions) must be reviewed and approved by the Client’s quality unit prior to before implementation unless otherwise agreed to in writing.
Appears in 1 contract