Process Validation. (a) 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, [*]. 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.
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.
Process Validation. Project approach to Process Validation will be done according to Cordis Quality System, Sterilization 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, Complaint .11andlinz/FAL See License Agreement for Complaint Handling and FAL. SECTION 2 — DESIGN & DEVELOPMENT SCHEDULE
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. ACSD will develop and complete a validation process at the Facility in accordance with Exhibit D herein, and at ACSD expense. [*] and limits for the process must span the [*]and limits developed and documented during the manufacture of consistency batches at [*]. No Process changes will be made during the period beginning on [*] and ending on the [*]. All post-validation process changes must be approved by Cubist in writing. Cubist will provide [*] and [*]as such reports become available. ACSD will provide Cubist with a [*]for the Facility and Process.
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 Manufactured Products. Such review shall be arranged by the Production Operating Teams.
Process Validation. E.15.1 The Manufacturing Process and control procedures (including, but not limited to cleaning procedures; aseptic procedures, process hold times, in-process stability, and development and justification of all processing parameters) shall be validated and qualified by BVL according to the Manufacturing Process Validation (MPV) plan for Product in the facility and using the equipment BVL intends to employ to make Product, as further defined in Section 15.2.
