FDA Good Laboratory Practices definition

FDA Good Laboratory Practices means the standards set forth in 21 C.F.R. Part 58 (and any foreign equivalent) and FDA’s implementing guidance documents (and any foreign equivalent).
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FDA Good Laboratory Practices means the regulations set forth in 21 C.F.R. Part 58.
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FDA Good Laboratory Practices means the standards set forth in 21 C.F.R. Part 58 (and any foreign equivalent), and as interpreted through applicable guidance documents by FDA (and foreign equivalents). “FDA Good Manufacturing Practices” means the standards set forth in 21 C.F.R. Part 820 (and any foreign equivalents), and as interpreted through applicable guidance documents by FDA (and foreign equivalents). “FDA Laws” means all applicable statutes (including the FDCA and the Public Health Service Act (42 U.S.C. § 262 through § 263) (the “PHSA”), rules and regulations implemented, administered, or enforced by the FDA and any United States state and foreign equivalents, and as interpreted through applicable guidance documents by the FDA (and United States state and foreign equivalents). “FDCA” is defined in Section 4.19(b).
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Examples of FDA Good Laboratory Practices in a sentence

  • Keep all Inventory which constitutes Product in good and marketable condition, free from material defects and otherwise keep all Inventory which constitutes Product in material compliance with all applicable FDA Laws, FDA Good Manufacturing Practices, FDA Good Clinical Practice, FDA Good Laboratory Practices and FDA Guidance Documents, as applicable.

  • Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities.

  • This study was performed using good documentation practices consistent with, but not in strict accordance with, the U.S. Food and Drug Administration (FDA) Good Laboratory Practices (GLP) regulations 21 CFR 58.

  • The basis of compliance is determined by the Federal Animal Welfare Act and Animal Welfare Regulations (AWAR), the Institute for Laboratory Animal Research (ILAR) Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Research and Teaching, the Public Health Service (PHS) Policy on the Care and Use of Laboratory Animals, the Food and Drug Administration (FDA) Good Laboratory Practices, and other applicable regulations.

  • Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 10.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, INI shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities.

  • NCI will require that clinical Studies must be conducted by Approved Investigators in accordance with the FDA Good Clinical Practices (GCP) and, if required by the applicable Proposal, Non-Clinical Studies must be conducted in accordance with the FDA Good Laboratory Practices (GLP).

  • Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Section 8.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities.

  • However, the risk concept is difficult to range in the graph presented above, since risk is a concept that concerns assessed future conditions; some of the objects in the graph are changing when it comes to risk assessment, e.g. ‘potential damage’ instead of ‘damage’.

  • Organizations awarded are responsible for ensuring that any procurement using CSLRFR funds, or payments under procurement contracts using such funds, are consistent with the procurement standards set forth in the Uniform Guidance at 2 CFR 200.317 through 2 CFR 200.327, as applicable.

  • The basis of compliance is determined by the Federal animal Welfare Act (P.L. 89-544) and amendments, the ILAR Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, the Public Health Service (PHS) Policy on the Care and Use of Laboratory Animals (hereafter called the PHS Policy), the Food and Drug Administration (FDA) Good Laboratory Practices, and other applicable regulations.

Related to FDA Good Laboratory Practices

  • Good Laboratory Practices or “GLP” means the then-current Good Laboratory Practice (or similar standards) for the performance of laboratory activities for pharmaceutical products as are required by applicable Regulatory Authorities or Applicable Law. In the United States, Good Laboratory Practices are established through FDA regulations (including 21 C.F.R. Part 58), FDA guidance, FDA current review and inspection standards and current industry standards.

  • Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, 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 having jurisdiction over the applicable activity.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Approved laboratory means a laboratory that is listed in the national conference of interstate milk shipments list of sanitation compliance and enforcement ratings distributed by the United States food and drug administration and as approved by the director.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • 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.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Good Industry Practice means standards, practices, methods and procedures conforming to the Law and the degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person or body engaged in a similar type of undertaking under the same or similar circumstances.

  • GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • GMPs means the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., as they may be updated from time to time. GMPs shall include applicable quality guidelines promulgated under the International Conference on Harmonization.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • cGLP means the current good laboratory practice regulations promulgated by the FDA, published at 21 C.F.R. § 58, and all applicable FDA rules, regulations, orders and guidances and equivalent or comparable non-United States regulations, rules, orders, guidances and standards in the Territory, as applicable, as such current laboratory practices, rules, regulations, orders, guidances and standards may be amended from time to time.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • cGCP means the then current Good Clinical Practices that establish the international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that are promulgated or endorsed for the United States by the FDA (including through ICH E6 and 21 CFR Parts 50, 54, 56 and 312) and for outside the United States by comparable Governmental Authorities.