PRODUCT AND PROCESS VALIDATION Sample Clauses

PRODUCT AND PROCESS VALIDATION. 11.1 Process - C*P is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the PRODUCTS acceptance specification.
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PRODUCT AND PROCESS VALIDATION. 13 ------------------------------ 11.1 Process............................................... 13 11.2
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PRODUCT AND PROCESS VALIDATION. 12.1 Process Validation– XERIS is responsible for ensuring the PYRAMID production process is validated for product. The validation should ensure the process is capable of effectively and reproducibly achieving the product acceptance specifications and quality attributes. PYRAMID shall provide adequate resources to execute process validations as per mutually approved protocols. XERIS is responsible for development and validation of the manufacturing process including processing hold times, formulation and process parameters, and filter validations. The activities may be contracted to PYRAMID, and if so, terms shall be outlined in the Master Services Agreement or in the Project Plan.
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PRODUCT AND PROCESS VALIDATION. 11.1 Process Validation—IDEC and BAXTER are responsible for ensuring that the manufacturing process is validated. BAXTER is responsible for ensuring that the facilities, utilities and support systems are validated. The validation should ensure that the process is capable of consistently achieving the PRODUCT acceptance specification. BAXTER shall provide adequate resources to execute process validations as per mutually approved protocols.
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PRODUCT AND PROCESS VALIDATION. 11.1 Process New River is responsible for ensuring that the process for Manufacture is validated. The validation should ensure that the process is capable of consistently achieving the Product’s acceptance Specifications. Patheon will generate, internally approve and execute approved validation protocol(s) and may not use any validation protocol or issue a report unless New River technical personnel and New River Quality Assurance have first approved. Patheon will provide all protocols and reports in a timely manner to allow sufficient tune for review, prior to process requirements. New River will review all protocols and validation reports promptly, but [***] of receipt.
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PRODUCT AND PROCESS VALIDATION. 11.1 Process Validation DSM is responsible for ensuring that the manufacturing process is validated. The validation should ensure, with a high degree of certainty, that the process is consistently capable of consistently achieving the Product’s acceptance criteria.
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PRODUCT AND PROCESS VALIDATION. 11.1 Process Validation ORPHAN is responsible for ensuring that the manufacturing process is validated. The validation should ensure that the process is capable of consistently achieving the Product acceptance specifications. ORPHAN will submit to CELLTECH copies of the Process Validation Reports as required by CELLTECH.
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PRODUCT AND PROCESS VALIDATION. In this phase, clearly-defined procedures are agreed with the customer, to, demonstrate that the proposed processes are able to manufacture the product in a controlled and capable manner.
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PRODUCT AND PROCESS VALIDATION 
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Related to PRODUCT AND PROCESS VALIDATION

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Quality Agreement If appropriate or if required by Applicable Law, the parties will also agree upon a Quality Agreement containing quality assurance provisions for the Manufacture of Product (“Quality Agreement”), which agreement will also be attached to the applicable Work Order and incorporated by reference in the Work Order.

  • Uncovering and Correction of Work 12 Uncovering of Work 12.1 Unforeseen Conditions, Concealed or Unknown 3.7.4, 8.3.1, 10.3 Unit Prices 7.3.3.2, 9.1.2

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Statement of Work The Contractor shall provide the services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • PRICE LISTS AND PRODUCT INFORMATION Contractors should provide an electronic version of the proposed price list in an Excel format or pdf on a jump drive. Also provide a dealer list, if applicable in an Excel format with "read and write" capabilities on the same jump drive. No costs or expenses associated with providing this information in the required format shall be charged to the State of Arkansas. At the time of contract renewal contractor will furnish OSP with an updated dealer list and published price list.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

  • Project Plan Development of Project Plan Upon the Authorized User’s request, the Contractor must develop a Project Plan. This Project Plan may include Implementation personnel, installation timeframes, escalation procedures and an acceptance plan as appropriate for the Services requested. Specific requirements of the plan will be defined in the RFQ. In response to the RFQ, the Contractor must agree to furnish all labor and supervision necessary to successfully perform Services procured from this Lot. Project Plan Document The Contractor will provide to the Authorized User, a Project Plan that may contain the following items: • Name of the Project Manager, Contact Phone Numbers and E-Mail Address; • Names of the Project Team Members, Contact Phone Numbers and E-Mail Address; • A list of Implementation milestones based on the Authorized User’s desired installation date; • A list of responsibilities of the Authorized User during system Implementation; • A list of designated Contractor Authorized Personnel; • Escalation procedures including management personnel contact numbers; • Full and complete documentation of all Implementation work; • Samples of knowledge transfer documentation; and • When applicable, a list of all materials and supplies required to complete the Implementation described in the RFQ. Materials and Supplies Required to Complete Implementation In the event that there are items required to complete an Implementation, the Contractor may request the items be added to its Contract if the items meet the scope of the Contract. Negotiation of Final Project Plan If the Authorized User chooses to require a full Project Plan, the State further reserves the right for Authorized Users to negotiate the final Project Plan with the apparent RFQ awardee. Such negotiation must not substantively change the scope of the RFQ plan, but can alter timeframes or other incidental factors of the final Project Plan. The Authorized User will provide the Contractor a minimum of five (5) business days’ notice of the final negotiation date. The Authorized User reserves the right to move to the next responsible and responsive bidder if Contractor negotiations are unsuccessful.

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