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.
Appears in 2 contracts
Sources: Commercial Manufacturing and Supply Agreement (Ophthotech Corp.), Clinical Manufacturing and Supply Agreement (Ophthotech Corp.)