Test Methods and Specifications. The Client will give Patheon a copy of the Specifications and test methods used if the Client issues raw material Specifications.
Test Methods and Specifications. The Client will give Patheon the finished Product Specifications . Patheon will validate the test methods used with assistance from the Client.
Test Methods and Specifications. The Client will provide to Patheon the CTM finished Product Specifications and will develop and supply validated analytical test methods to Patheon for the CTM finished Product. If the test methods and procedures are not validated by the Client, then Patheon may assist in validation development with [***].
Test Methods and Specifications. CPI will manufacture and test Drug Resin Complex materials in accordance with the test methods and the Specifications.
Test Methods and Specifications. Cangene will give Patheon a copy of the Specifications and test methods used if Cangene issues raw material Specifications as well as any relevant updates. Per each raw material delivered to Patheon a MSDS document will be provided by Cangene to detail the handling procedures.
Test Methods and Specifications. Cangene will provide to Patheon the finished In Process Control (IPC) and release Product Specifications and will develop and supply validated analytical test methods to Patheon for the finished Product at release (and shelf-life testing if requested). Patheon is responsible to verify the performance of test methods in the actual condition of use.
Test Methods and Specifications. Synageva will give Patheon a copy of the Specifications and test methods used if Synageva issues Raw material Specifications as well as any relevant updates. Per each Raw material delivered to Patheon a MSDS document will be provided by Synageva to detail the manipulation procedures.
Test Methods and Specifications. Synageva will provide to Patheon the finished Product Specifications and will develop and supply validated analytical test methods or results to Patheon for the finished Product at release (and shelf-life if requested). Patheon is responsible to verify the performance of test methods in the actual condition of use for any assays run within Patheon’s control.
Test Methods and Specifications. CPI will analyze the Drug Resin Complex in accordance with the validated test methods and the Specifications.
Test Methods and Specifications. Penwest will give Patheon a copy of the Specifications and test methods to be used if Penwest issues Component Specifications. Patheon will create internal test methods and specifications in support of the Components; provided that all QC testing for Components will be conducted by Patheon using the methods and Specifications provided by Penwest to Patheon, or otherwise approved by Penwest in writing. Raw materials used in manufacture of Products hereunder shall be released as per USP/NF/EP or to Penwest’s specifications, as approved in writing by Penwest.
