Good Laboratory Practice Sample Clauses

Good Laboratory Practice or GLP shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding quality control for laboratories to ensure the consistency and reliability of results, including without limitation the CFR Title 21, national legislation implementing European Community Directive 2004/9/EC of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) as amended and European Community Directive 2004/10/EC of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances as amended, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring.
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Good Laboratory Practice. This study will be conducted under the guidelines of Good Laboratory Practice as promulgated by the Food and Drug Xxxxxxxxxxxxxx 00 XXX 00.
Good Laboratory Practice. 5.1 Supplier shall: (a) perform the Services with the highest professional standards, in a good scientific manner, in compliance with the provisions of this Agreement and all Applicable Laws, including as applicable, GLP, and (b) ensure that it has all licenses and consents required to provide the Services and otherwise conduct its business, and shall maintain and comply with all such licenses and consents.
Good Laboratory Practice. The termGood Laboratory Practices” shall mean the then-current standards for good laboratory practices for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidance promulgated thereunder, including the Code of Federal Regulations, as amended from time to time, or under any other Applicable Law.
Good Laboratory Practice. (GLP) Scope and coverage The provisions of this Chapter shall apply to the testing of chemicals according to GLP, being either substances or preparations, covered by the legislative, regulatory and administrative provisions listed in Section I. For the purposes of this Chapter the provisions of Article 4 of this Agreement concerning origin do not apply. Unless specific definitions are given, the definition of terms in the "OECD Principles of Good Laboratory Practice" as revised in 1997 [ENV/MC/CHEM(98)17] based on OECD Council Decision of 12 May 1981 C(81)30(Final)] amended on 26. November 1997 [C(97) 186 FINAL], as well as Council Decision- Recommendation of 2 October 1989 [C(89)87(Final)] amended on 9 March 1995 [C(95)8(Final)] and GLP Consensus documents, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, and all amendments made thereto, shall apply. The Parties recognise the equivalence of each other's compliance monitoring programmes on Good Laboratory Practice that are in accordance with the OECD decisions and recommendations mentioned above and the legislative, regulatory and administrative procedures and principles listed in section IV. The Parties mutually accept studies and data generated therefrom, produced by the test facilities of the other Party provided they participate in the Good Laboratory Practice compliance monitoring programme of that Party in accordance with the principles and provisions stated above. The Parties mutually accept the conclusions of study audits and test facility inspections performed by the GLP monitoring authorities
Good Laboratory Practice. 5 Section 1.28. GOOD MANUFACTURING PRACTICE..................................................5 Section 1.29. INDEMNIFIED PARTY(IES).......................................................6 Section 1.30. INDEMNIFYING PARTY...........................................................6 Section 1.31. KNOW-HOW.....................................................................6 Section 1.32. LICENSED PRODUCT(S)..........................................................6 Section 1.33. LOCK UP PERIOD...............................................................6 Section 1.34.
Good Laboratory Practice. Good Laboratory Practice shall mean the current good laboratory practice applicable to the Development of the Product under applicable Law, to the extent such standards are not less stringent than the U.S. current good laboratory practice, including without limitation 21 C.F.R. Part 58.
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Good Laboratory Practice. (GLP) The generation of test data related to the safety of industrial chemical and biological substances must be performed in compliance with GLP to ensure quality and reliability. 3.6. Health of Employees All activities should be conducted in order to avoid risks to employee health and safety. 3.7. Environment All activities should be respectful of the environment, in compliance with all applicable laws and regulations. 3.8. Animal Welfare Animals used in research activities must be treated respectfully and animal testing should be performed in compliance with the Three Rs principles of Refinement, Reduction and Replacement. 4. INTEGRITY 4.1. Anti-bribery Practices The legal definition of bribery varies from one country to another, but it always means: ‘‘the act of offering something in order to obtain an undue interest or advantage’’. Because bribery distorts fair trade, hinders economic development, and imposes multiple costs on society at large, any form of bribery or corruption will not be tolerated. 4.2. Conflict of Interest Any situation where there is an actual, apparent or perceived conflict of interest must be avoided or disclosed to be dealt with appropriately. 4.3. Fair Competition All activities must be conducted in compliance with applicable competition/antitrust laws and regulations. 4.4. Intellectual Property Rights - Confidentiality - Data Protection Any information protected by patents, trademarks, copyright, trade secret laws or the Intellectual Property Rights shall be respected in compliance with all applicable laws and regulations. Confidential information must be properly used, at all times, in an ethical manner and must be protected against theft, damage, misappropriation or misuse. Data protection laws and regulations should be respected.
Good Laboratory Practice. The Research Program shall be conducted by CISTRON at CISTRON's laboratories and/or at Third-Party research laboratories contracted by CISTRON. CISTRON shall use all reasonable efforts to complete research works in accordance with the said Program. Any research work performed by CISTRON pursuant hereto shall be in compliance with current Good Laboratory Practices (cGLP) as applicable in the United States of America.

Related to Good Laboratory Practice

  • Good Industry Practice 11.1.4 all applicable Standards; and

  • GMP The parties agree that the GMP for the Project is $ , consisting of the Preconstruction Fee, the Estimated Cost of the Work and the CM/GC Fee (stated as a fixed dollar lump sum amount), as follows: Preconstruction Fee: $ Estimated Cost of Work (Est. COW): $ CM/GC Fee ( % of Est. COW): $ GMP (Total of above categories): $ For purposes of determining the GMP, the Estimated Cost of the Work includes the CM/GC’s Contingency, costs for General Conditions Work, and the costs of all components and systems required for a complete, fully functional facility.

  • Good industry practices 12.1.1. SAP warrants that: a) its Services will be performed in a professional xxxxxxx-like manner by Consultants with the skills reasonably required for the Services; and

  • Unfair Labor Practices The Grantee shall comply with the Employers Engaging in Unfair Labor Practices Act, 1980 PA 278, as amended, MCL 423.321 et seq.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • SAFETY PRACTICES (a) The employer will take reasonable measures to prevent and eliminate any present or potential job hazards which the employees may encounter at their places of work.

  • Manufacturing Standards All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. Agreement No. Sort # Scaling Rule 97318 3 WS Average Log Length Preferred Log Lengths "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract.

  • Development Standards 9.1 Developer shall comply with the requirements contained in the Annexation Agreement and any other duly executed agreement related to the Property, except as specifically amended by this Agreement.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Hiring Practices The Board shall, in all instances, employ teachers who are properly credentialed in accordance with applicable state laws, Washington Administrative Code, and by such other requirements as specified by the Office of the State Superintendent of Public Education. Classified personnel shall not be assigned to perform work in the instructional setting which will replace a currently employed certificated employee in his assignment or employment.

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