Environmental Monitoring Program. Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the responsible person within Patheon’s quality unit. Any out of limit results will be managed appropriately in accordance with Patheon SOPs.
Appears in 6 contracts
Samples: Product Agreement (La Jolla Pharmaceutical Co), Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Product Agreement (Tetraphase Pharmaceuticals Inc)
Environmental Monitoring Program. Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the responsible person within Patheon’s quality unit. Any out of limit results will be managed appropriately in accordance with Patheon SOPsSOP’s.
Appears in 4 contracts
Samples: Supply Agreement (Relypsa Inc), Supply Agreement (Relypsa Inc), Manufacturing Services Agreement (Medicines Co /De)
Environmental Monitoring Program. Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the responsible person within Patheon’s quality unit. Any out of limit results will be managed appropriately in accordance with Patheon SOPsSOP’s. If any of the out of limit results have an impact on the Product then Synageva will be notified within one (1) Business Day.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Synageva Biopharma Corp)
Environmental Monitoring Program. Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the responsible person within Patheon’s quality unit. Any out of limit results impacting the Product will be reported immediately to Penwest and managed appropriately in accordance with Patheon SOPs.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)
