Process Validations Sample Clauses
Process Validations. Process Validations, e.g., Operational Qualification-Process (“OQ-P”) and PQ shall have approved protocols and test reports which include test data, results, date and signature of the individual(s) approving the validation and where appropriate the major equipment validated.
Process Validations. Meridian shall perform process validations of the manufacturing processes in accordance with the Specifications and all applicable laws in the Territory and shall make records of such validations. All costs and expenses necessary for such process validations which are required by the cGMPs shall be paid by Meridian. All costs and expenses necessary for such process validations which are not required by the cGMPs, but are requested by Dey ▇▇ required by any country in the Territory other than the United States in which Dey (▇▇ a sub-distributor) is marketing, distributing or selling the Products or proposes to market, distribute or sell the Products, shall be paid by Dey. ▇▇ridian shall make such validation records available to Dey ▇▇▇ review at Meridian's manufacturing facility in accordance with Section 15a.