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.
Good Laboratory Practice means 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.
Good Laboratory Practice means the current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (“OECD”), as amended from time to time, and such standards of good laboratory practice as are required by the EMA and other organizations and governmental agencies in Major EU Countries, to the extent such standards are not less stringent than United States Good Laboratory Practice.
Examples of Good Laboratory Practice in a sentence
In accordance with Article 12 of this Agreement, the Parties in particular provide each other at least annually with a list of the test facilities which, in the light of the results of the inspections and study audits, conform to Good Laboratory Practice, as well as of the dates of inspection or audit and their compliance status.
In accordance with Article 6 of the Agreement, the Parties shall inform each other in a timely manner when a test facility coming under the terms of section II of this sectoral Chapter which states that it applies Good Laboratory Practice fails to conform to such practice to an extent which may jeopardise the integrity or authenticity of any such studies it conducts.
Each Party may request further test facility inspection or study audits if there is a documented doubt as to whether a test was conducted in accordance with Good Laboratory Practice.
The definitions in sec- tion 3 of TSCA and in part 792 of this chapter, Good Laboratory Practice Standards, apply to this test guideline.
The University’s Animal Care and Use program does not conduct studies subject to the FDA Good Laboratory Practice (GLP) regulations.
More Definitions of Good Laboratory Practice
Good Laboratory Practice means all applicable then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58 or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (OECD), and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in countries in which a Product is intended to be sold, to the extent such standards are not less stringent than United States Good Laboratory Practice.
Good Laboratory Practice means the applicable principles and guidelines for good laboratory practice for drugs and medicinal products, as such principles and guidelines are amended, implemented and supplemented from time-to-time, including without limitation those set out in the OECD Principles of Good Laboratory Practice published by the Organisation for Economic Co-Operation and Development.
Good Laboratory Practice or "GLP" shall mean the then current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time, and any other applicable requirements for laboratory activities under the laws, rules or regulations of the Territory.
Good Laboratory Practice means a practice as defined in point 2.1 of Annex I to Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the appli cation of the principles of good laboratory practice and the verifi cation of their applications for tests on chemical substances (2);
Good Laboratory Practice means the then current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good laboratory practice as are required by the European Union and other Regulatory Authorities in countries in which the Product is intended to be sold, to the extent such standards are not in contravention with United States Good Laboratory Practices.
Good Laboratory Practice means all applicable then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58, the PRC Good Clinical Practice effective as of September 1, 2003, or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (OECD), and such standards of good laboratory practice as are required by the equivalent applicable Laws in the relevant Region and other organizations and governmental agencies in countries in which the Licensed Product is intended to be sold by the Party that is subject to such standards.
Good Laboratory Practice. Good Laboratory Practice means the current good laboratory practice applicable to the Development of Licensed Product under applicable Law, to the extent such standards are not less stringent than the U.S. current good laboratory practice, including 21 C.F.R. Part 58.