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 SOPs. The Client will provide to Patheon the API Specifications for furnished API, including a certificate of analysis for each batch. 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. 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.
4.6.2.2. Critical Raw Materials — Agilent will make recommendations for any change in Critical Raw Material Specifications and test methods as necessary to assure quality and compliance. The establishment of formal Critical Raw Material Specifications and test methods will occur per Agilent’s internal procedures.
4.6.2.3. In-Process — Ophthotech and Agilent will agree on in-process Specifications and test methods used during development. The establishment of in-process Specifications and test methods for validation and commercial manufacturing will occur per Agilent’s internal procedures and shall be subject to approval by Ophthotech.
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. 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 [***].
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. 8.1. Jazz Pharmaceuticals will provide Patheon all Specifications for the API, raw materials, packaging materials and the Product.
8.2. Jazz Pharmaceuticals will provide Patheon all test methods for testing the API and the Product.
8.3. Patheon will send Jazz Pharmaceuticals all specifications for the API and the Product for review and approval.
8.4. Patheon will send Jazz Pharmaceuticals all test methods for testing the API and the Product for review and approval.
8.5. Any changes to the approved Product Specifications and test methods must be sent to Jazz Pharmaceuticals for review and approval. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Specifications and Test Methods. Patheon will test and approve the finished Product in accordance with the approved Specifications, cGMP, analytical methods, and Patheon’s SOP’s.
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.
