Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOPs. Quality Agreement QG01-05-T001-01 Page14of18 The Client will give Patheon the Active Material Specifications including a CoA. The Client will give Patheon the test methods for Active Material (if non -compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development at Client’s cost.
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Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC)
Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOPs. Quality Agreement QG01-05-T001-01 Page14of18 Patheon will provide copies of the internal versions of the analytical test methods to Client. The Client will give Patheon the Active Material Specifications including a CoA. certificate of analysis The Client will give Patheon the test methods for Active Material and excipient’s (if non -compendialnon-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development at Client’s cost.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOPs. Quality Agreement QG01-05-T001-01 Page14of18 The Client will give Patheon the Active Material Specifications including a CoA. certificate of analysis. The Client will give Patheon the test methods for Active Material and excipients (if non -compendialnon-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development at Client’s costcost and at Client’s written request.
Appears in 1 contract
Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOPsSOP’s. Quality Agreement QG01-05-T001-01 Page14of18 The Client will give provide to Patheon the Active Material Specifications including a CoA. certificate of analysis The Client will give provide to Patheon the test methods for Active Material and excipients (if non -compendialnon-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development at with the costs being borne by the Client’s cost.
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