Process Validation. Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of as- surance and approved according to es- tablished procedures. The validation activities and results, including the
Process Validation. If the output of a Supplier’s process is not fully verified by subsequent inspection or test, the Supplier shall validate the process with a high degree of assurance, typically demonstrating a Cpk ≥
Process Validation. 7.9.1 Processes outputs that cannot be fully verified by subsequent measurement or other means of verification shall be validated to ensure they will consistently meet the design requirements.
7.9.2 The validation shall be performed according to an approved validation plan. Xxxxxx Scientific reserves the right to review and approve the validation plan.
7.9.3 Production intent materials, tooling, processes, and sub-suppliers should be used to produce products for validation testing. Xxxxxx Scientific may require product for testing requirements.
Process Validation. Project approach to Process Validation will be done according to Cordis Quality System, The Sterilization strategy is to be 3X EtO capable, which will be the same as current marketed devices (self expandable stents), Previous Cordis validations will be leveraged for sterilization. DV/PPQ units for both product and its packaging for the 18 new Carotid Stent Delivery System catalogs - 65cm length will be subjected to three EtO sterilization cycles, See License Agreement for Complaint Handling and FAL.
Process Validation. Project approach to Process Validation will be done according to Cordis Quality System.
Process Validation. Fresenius is responsible for the validation of the manufacturing process for PRODUCTS, as might be required. The validation should ensure that the process is capable of consistently achieving the Production Standards and Testing Specifications. Validation protocols and reports should be available for review before shipment upon request.
Process Validation. Bachem will ensure that the manufacturing process used is fully validated, approved by Bachem’s Quality Assurance and Regulatory Affairs groups and meets Competent Authorities requirements. Bachem will document the process validation, and at Xeris’ request, disclose such documentation to Xeris for on-site review at Bachem.
Process Validation. ACSD will develop and complete a validation process at the Facility in accordance with Exhibit D herein, and [*]. Validation parameters and limits for the process must span the actual process parameters and limits developed and documented during the manufacture of consistency batches at commercial scale. All post-validation process changes [*]. Cubist will provide test method validation reports and small-scale purification validation studies as such reports become available. ACSD will provide Cubist with a master validation plan for the Facility and Process.
Process Validation. During the Term, at Newco's request, Xxxxxx and its Subcontractors shall permit Newco to review production validation protocols and results with respect to the Supplied Products. Such reviews shall be arranged by the Production Operating Teams.
Process Validation. If the output of a Supplier’s process is not fully verified by subsequent inspection or test, the Supplier shall validate the process with a high degree of assurance, [*]. The validation process shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). All validated process changes shall be similarly validated prior to use. The Supplier shall keep records of these activities and make them available to the Purchaser upon request. When the Supplier ships products produced using a validated process, the Supplier shall include process documentation showing the date the process was operated, the name of the operator, the identity of major equipment used, the identity and calibration date of the IM&TE used in the process, and the setting of each input process parameter.
