Common use of Master Batch Packaging Records Clause in Contracts

Master Batch Packaging Records. The Client will 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 (before Master revisions) must be reviewed and approved by the Client’s quality unit 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)

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Master Batch Packaging Records. The Client client will approve 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 (before Master prior to master revisions) must be reviewed and approved by the Client’s quality unit before 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 will approve 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 (before prior to Master revisions) must be reviewed and approved by the Client’s quality unit before Client prior to implementation unless otherwise agreed to in writing.

Appears in 1 contract

Samples: Avanir Pharmaceuticals, Inc.

Master Batch Packaging Records. The Client will approve give Patheon 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 (before Master revisions) must be reviewed and approved by the Client’s quality unit before implementation unless otherwise agreed to in writing.

Appears in 1 contract

Samples: Quality Agreement (Jaguar Animal Health, Inc.)

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Master Batch Packaging Records. The Client will approve give Patheon the Specifications for all packaging components. Patheon will create, control, issue, and execute in accordance with the master batch packaging record and the Specifications. The Client is responsible to review and approve the master batch records before the packaging of the Product. 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 (before Master revisions) must be reviewed and approved by the Client’s quality unit before implementation unless otherwise agreed to in writing.

Appears in 1 contract

Samples: Product Agreement (Horizon Pharma, Inc.)

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