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.
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 SOP’s. Upon receipt, the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Cangene. Cangene will provide to Patheon the Active Material Specifications. Cangene will provide to Patheon test methods for Active Material and excipient’s (if non-compendial). Cangene is responsible for validating non-compendial testing methods. If these methods are not validated by Cangene, then Patheon may assist in validation development with the costs being borne by Cangene.
Specifications and Test Methods. CPI will test and approve starting materials, intermediates, and Drug Resin Complex in accordance with the Specifications, cGMP and the SOPs.
Specifications and Test Methods. 4.6.2.1. Agilent will follow written quality system procedures for the identification, quarantine, handling, sampling, testing and approval or rejection of materials. Agilent will perform testing per established methods/procedures and review results against the Specifications. Changes to these methods and procedures will be consistent with the Change Management section of this Agreement. Deviations to the test methods and procedures and OOS results will be handled in a manner consistent with the Deviation and OOS sections of this agreement.
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. The Client will provide to Patheon the API Specifications for furnished API, including a certificate of analysis for each batch. Master Manufacturing Services Agreement The Client will supply any required reference standards that are not readily available through a commonly recognized source. These reference standards must be accompanied by a Certificate of Analysis listing the expiration date and any correction factors that need to be applied.
Specifications and Test Methods. Patheon will test and approve starting material, in-process materials, and the Product in accordance with the approved Specifications, analytical methods, and Patheon’s SOP’s. MDCO will provide Patheon with the API Specifications including the manufacturer’s Certificate of Analysis. Patheon will be responsible for performing only an assay and ID testing on the API. MDCO will provide Patheon with test methods for API and excipients (if non-compendial). Patheon is responsible for validating non-compendial testing methods.
Specifications and Test Methods. SUPPLIER will test and disposition raw material(s); will perform in-process control testing in accordance with the approved specifications, validated and/or verified analytical methods, and SUPPLIER’s SOPs.
Specifications and Test Methods. 8.1. Jazz Pharmaceuticals will provide Patheon all Specifications for the API, raw materials, packaging materials and the Product.
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 SOP’s. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Upon receipt, the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Synageva. Synageva will provide to Patheon the BDS Specifications including a certificate of analysis. Synageva will provide to Patheon test methods for BDS [**]. Synageva is responsible for validating non-compendial testing methods. If these methods are not validated by Synageva, then Patheon may assist in validation development with the costs being borne by Synageva, subject to Synageva’s prior written approval.
Specifications and Test Methods. Patheon will test and approve starting material, intermediate, and the CTM in accordance with the approved Specifications, analytical methods, and Patheon’s SOP’s. The Client will provide to Patheon the Active Material Specifications including a certificate of analysis. The Client will provide to Patheon test methods for Active Material and excipient’s (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 with [***].
