cGMP definition

cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

cGMP means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Authority.

cGMP means the regulatory requirements for the then-current good manufacturing practice as provided for (and as amended from time to time) in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (21 CFR §§ 210 and 211), in Part C, Division 2 of the Food and Drug Regulations (Canada) and in Commission Directive 2003/94/EC, as amended from time to time and the principles and practices set down in the current edition of the Rules Governing Medicinal Products in the European Union, Volume IV, Good Manufacturing Practice for Medicinal Products.

Examples of cGMP in a sentence

• The Company shall promptly take or cause to be taken (and shall cause its Subsidiaries to promptly take or cause to be taken) all steps necessary to update the records of the applicable domain name registrar to ensure that such transfer, conveyance and assignment has been recorded and that RBS is the sole and exclusive owner of the Retained RBS Domain Names.

• The Licensor shall notify the Licensee as soon as reasonably practicable after becoming aware of any challenge to the validity of any of the [RBS]/[NatWest] Trade Marks [or the RBS Domain Names] that comes to its attention and which may adversely affect the Licensee’s use of the same pursuant to the terms of this Agreement.

• The Licensor shall take reasonable steps to maintain the [RBS]/[NatWest] Trade Marks [and the RBS Domain Names] during the Term, save that the parties hereby acknowledge that the Licensor may, upon reasonable notice to the Licensee at its sole discretion, withdraw Canadian trade xxxx applications nos.

• The Licensor does not make, nor shall be deemed to have made, to the Licensee any representation or warranty in this Agreement with respect to any of the [RBS]/[NatWest] Trade Marks [or the RBS Domain Names] save as expressly set out herein.

More Definitions of cGMP

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.

cGMP means current Good Manufacturing Practices as specified in Parts 210 and 211 of Title 21 of the U.S. C.F.R., ICH Guideline Q7A, or equivalent Laws of an applicable Regulatory Authority at the time of manufacture.

cGMP means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.

cGMP means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.

cGMP means current Good Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of the U.S. Code of Federal Regulations, as may be amended from time to time, or any successor thereto.

cGMP means current Good Manufacturing Practices as established by the FDA as the same may be amended from time to time.

cGMP means current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211 as amended from time to time.