Current Good Laboratory Practice means laboratory practice as set out in: (i) Rules Governing Medicinal Products in the European Union Vol. III, ISBN 92.825 9619-2 (ex. OECD principles of GLP), as may be amended from time to time; (ii) US Code of Federal Regulations, Title 21, Chapter 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), and relevant final FDA Guidance and Points to Consider for drugs and/or biotechnology-derived products, as may be amended from time to time; or (iii) the equivalent current law or regulation in any market.
Current 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 applicable Regulatory Authority in the Territory.
Current Good Laboratory Practice or “cGLP” means the then-current good laboratory practices, as set forth in the United States Code of Federal Regulations Title 21, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies promulgated or endorsed by the FDA, or equivalent Laws, rules or regulations of an applicable Regulatory Authority at the time of the laboratory studies.
Examples of Current Good Laboratory Practice in a sentence
SuperGen shall ensure that the development activities it undertakes pursuant to Article 3 and Article 4 hereof shall be carried out in accordance with Current Good Clinical Practice, Current Good Laboratory Practice and Current Good Manufacturing Practice.
Both Parties shall ensure that the development activities undertaken pursuant to Article 3 and Article 4 hereof shall be carried out in accordance with Current Good Clinical Practice, Current Good Laboratory Practice and Current Good Manufacturing Practice.
Initiate an appropriately designed pre-clinical animal study, as described above, to be conducted under Current Good Laboratory Practice, as will be required for regulatory submission, by the end of 2011.
It must be compliant with Current Good Manufacturing Practices (CGMP) standards and Current Good Laboratory Practice (CGLP) standards.
A132 (¶ 73).In 2013, Biocad opened a new large-scale production site in Russia designed to conform to FDA standards for Current Good Manufacturing Practice and Current Good Laboratory Practice.
More Definitions of Current Good Laboratory Practice
Current Good Laboratory Practice means laboratory practice as set out in:
Current Good Laboratory Practice means laboratory practice as set out in: (i) Rules Governing Medicinal Products in the European Union Vol. III,
Current Good Laboratory Practice or “cGLP” shall mean the framework within which: (i) laboratory studies are planned, performed, monitored, recorded, reported and archived as defined under 21 CFR 58, OECD Principles on Good Laboratory Practice (ENV/MC/Chem (98)17), Directive 2004/10/EC and equivalent regulations in regulatory Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. jurisdictions within the Territory; and (ii) Good Laboratory Practice is inspected and verified, as set out in Directive 2004/9/EC and equivalent regulations in regulatory jurisdictions within the Territory, in all cases as amended from time to time.
Current Good Laboratory Practice or “cGLP” shall mean the framework within which: (i) laboratory studies are planned, performed, monitored, recorded, reported and archived as defined under OECD Principles on Good Laboratory Practice (ENV/MC/Chem (98)17) and rules in force in the European Union relating to Good Laboratory Practice including EC Directives 2004/10/EC, 87/18 EEC, and 1999/11/EC and equivalent regulations in regulatory jurisdictions within the Territory; and (iii) Good Laboratory Practice is inspected and verified, as set out in EC Directives 2004/9/EC and 88/320/EEC and equivalent regulations in regulatory jurisdictions within the Territory, in all cases as amended from time to time.
Current Good Laboratory Practice or "cGLP" shall mean the current guidelines for the principles of good laboratory practice as set out in the EU Directives 2004/9/EC and 2004/10/EC and the related OECD principles and FDA's GLP regulations so far as the same are relevant in each case as amended and updated from time to time;
Current Good Laboratory Practice means laboratory practice as set out in: (i) Rules Governing Medicinal Products in the European Union Vol. III, ISBN 92.825 9619-2 (ex. OECD principles of GLP), as may be amended from time to time; (ii) US Code of Federal Regulations, Title 21, Chapter
Current Good Laboratory Practice means the applicable then- current standards for laboratory activities for pharmaceuticals or biologicals, as set forth in the Act -4- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED