GLP definition

GLP means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable foreign regulatory standards.

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GLP or “Good Laboratory Practice” shall mean the applicable then-current standards for laboratory activities for pharmaceuticals or biologicals, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority in the Territory.

GLP means the current Good Laboratory Practice (or similar standards) for the performance of laboratory activities for pharmaceutical products as are required by applicable Regulatory Authorities. In the United States, Good Laboratory Practices are established through FDA regulations (including 21 CFR Part 58), FDA guidances, FDA current review and inspection standards and current industry standards.

Examples of GLP in a sentence

Janux, its Affiliates and its and their respective contractors and consultants have conducted (including the generation, preparation, maintenance and retention of documentation with respect thereto) all Development and Manufacture of the Licensed Compounds and Licensed Products in accordance with Applicable Law (including GLP, GCP, GMP as applicable).
Each Party (and its Affiliates) shall, and shall require that its other Related Parties and its and their respective contractors and consultants, conduct (including the generation, preparation, maintenance and retention of documentation with respect thereto) all Development, Manufacture and other Exploitation of the Licensed Compounds and Licensed Products in accordance with Applicable Law (including GLP, GCP, GMP as applicable).
Such reports, records and documentation shall fully and properly reflect all work done and results achieved in the performance of such Joint Development Activities or other Development activities in good scientific manner and appropriate for regulatory and patent purposes, and shall be prepared and maintained in accordance with Applicable Law, including, to the extent applicable, GLP, GCP and GMP recordkeeping requirements.
Each Party (and its Affiliates) shall, and shall require that its subcontractors, conduct activities under the Joint Development Plan in compliance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP), in good scientific manner and consistent with good business ethics, and each Party will promptly notify the other Party in writing after it becomes aware of any deviations from any of the foregoing.

More Definitions of GLP

GLP means all applicable then-current good laboratory practice standards as are promulgated by applicable Regulatory Authorities in the relevant country or other jurisdiction, including: (a) in the United States, those promulgated or endorsed by the FDA in U.S. 21 C.F.R. Part 58, as may be applicable from time to time; and (b) the equivalent practices, standards and regulations promulgated or endorsed by the applicable Regulatory Authorities outside the United States, as may be applicable from time to time, to the extent such practices, standards and regulations are not less stringent than United States GLP.

GLP means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

GLP means current good laboratory practices as established by the FDA and as interpreted by relevant ICH guidelines; in each case, as amended from time to time.

GLP means the current Good Laboratory Practices regulations promulgated by the FDA, published at 21 CFR Part 58, as such regulations may be from time to time amended, and such equivalent regulations or standards of countries outside the United States as may be applicable to activities conducted hereunder.

GLP means current Good Laboratory Practices as specified in the United States Code of Federal Regulations at 21 CFR § 58 at the time of testing and all applicable ICH guidelines.

GLP means the applicable then-current standards for laboratory activities for pharmaceuticals or biologicals, as set forth in 21 C.F.R. part 58, as amended from time to time, or guidance documents promulgated thereunder, together with any similar standards of good laboratory practice as are required by any Regulatory Authority in any applicable jurisdiction.

GLP means the applicable good laboratory practice as required by the applicable Regulatory Authorities, including under 21 C.F.R. Part 58 and all related FDA rules, regulations, and orders, and the requirements with respect to good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by applicable Law.