Master Batch Record. The Client 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, the Client is responsible to review and approve the master batch records prior to the manufacture of the Product unless otherwise agreed to in writing. 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 unless otherwise agreed to in writing. 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. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.
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Samples: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)
Master Batch Record. The Client will provide give Patheon 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, the . The Client is responsible to review and approve the master batch records prior to before the manufacture of the Product unless otherwise agreed to in writingProduct. 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 unless otherwise agreed prior to in writingimplementation. Any changes made to issued batch records (prior to before master revisions) must be reviewed and approved by the Client’s quality unit prior to before implementation unless otherwise agreed to in writing. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.
Appears in 1 contract
Master Batch Record. The Client 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, the Client is responsible to review and approve the such master batch records prior to the manufacture of the Product unless otherwise agreed to in writingProduct. 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 unless otherwise agreed to in writingClient . 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. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.
Appears in 1 contract