Material Traceability Sample Clauses

Material Traceability. As applicable, the supplier may be required to establish a lot traceability system that tracks raw material lot / batch numbers to the finished product lot / batch numbers including traceability to inspection records.
Sample 1Sample 2
AutoNDA by SimpleDocs
Material Traceability. The certification data report shall be identified through a unique traceability number, heat-lot number, or heat-treat number for metallic material or batch of non-metallic material, as applicable, which shall also be marked on the material. This traceability marking on the material shall provide direct traceability to the material's chemical composition and mechanical properties certification data. For material produced by batch, continuous cast, or continuous pour processes, samples shall be taken no less than once in every eight hours of operation for the purpose of validating proper chemical composition and mechanical properties. Traceability shall be maintained through all process operations including any subcontracted operations, to the finished component.
Sample 1
Material Traceability. Traceability shall be maintained between the material and its quantitative test reports through a unique traceability number, heat-lot number, or heat- treat number as applicable, which shall also be marked on the material. Control must be established to retain this number in association with the material during machining. This traceability number marked on the material shall provide direct traceability to the materials chemical composition and mechanical property certification data.
Sample 1
Material Traceability. Materials used must be identified by material type, applicable specification and revision number, and be traceable to their lot and/or heat number(s). Traceability records shall be available for review by the Buyer’s representative.
Sample 1
Material Traceability. GenMark is responsible for identifying critical Materials that require component level traceability. GenMark shall select the appropriate component level or device level traceability grade, in order to meet any applicable regulations or requirements of Governmental Authorities.
Sample 1
Material Traceability. Seller shall assure that records are maintained for traceability of all regulatory controlled parts listed in agency reports. Regulatory controlled parts must be traceable to the source of manufacture by lot or date code, and must be traceable through the manufacturing process to their final destination via serialization of finished Material. Such information will be shared with Buyer upon request. Finished Material shipped to Buyer shall be serialized in accordance with the requirements of Buyer's Purchase/Engineering Specification. The general format shall be SSYWWxxxxx, where SS is the Seller's supplier code (assigned by the Buyer), Y is the last digit of the calendar year, WW is the calendar week, and xxxxx is a unique, sequential, 5-digit alpha-numeric sequence.
Sample 1
Material Traceability. The Supplier must maintain an effective system for material traceability by heat, lot or batch number; back to its ultimate mill source, including any intermediate sub-tier suppliers. No substitution of material composition, size or specification is allowed unless authorized by Ameriflex Inc. by means of an amended PO. The Supplier must maintain raw material test report(s) applicable to the products furnished under this order available to Ameriflex Inc., for at least 15 years. Counterfeit Parts & Material Prevention - “Counterfeit Parts and Material” are (or contain) items misrepresented as having been designed and/or produced under an approved system or other acceptable method. The term also includes approved items that have reached a design life limit or have been damaged beyond possible repair and have been altered and misrepresented as acceptable. Should the supplier become aware that counterfeit parts have been furnished to Ameriflex Inc., the supplier must notify Ameriflex Inc. immediately with the data necessary to identify and recall such parts.
Sample 1
AutoNDA by SimpleDocs
Material Traceability. Goods and Services supplied against this Order require full traceability of parts and constituent materials from the time of receipt at the Seller through to delivery of the finished article. Raw material traceability is required to the physical and chemical analysis. If the Seller is not the original manufacturer of the Goods or Services, the Seller shall also provide with the delivery of each consignment, copies of the original manufacturer’s certificate of conformity /release note together with test results etc., where applicable.
Sample 1

Related to Material Traceability

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • O.S.H.A. and Environmental Compliance (a) Each Borrower has duly complied with, and its facilities, business, assets, property, leaseholds, Real Property and Equipment are in compliance in all material respects with, the provisions of the Federal Occupational Safety and Health Act, the Environmental Protection Act, RCRA and all other Environmental Laws; there have been no outstanding citations, notices or orders of non-compliance issued to any Borrower or relating to its business, assets, property, leaseholds or Equipment under any such laws, rules or regulations.

  • Compatibility 1. Any unresolved issue arising from a mutual agreement procedure case otherwise within the scope of the arbitration process provided for in this Article and Articles 25A to 25G shall not be submitted to arbitration if the issue falls within the scope of a case with respect to which an arbitration panel or similar body has previously been set up in accordance with a bilateral or multilateral convention that provides for mandatory binding arbitration of unresolved issues arising from a mutual agreement procedure case.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Stability Testing Patheon may be requested to conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client ail stability test data and results at Client’s request.

Time is Money Join Law Insider Premium to draft better contracts faster.