Current Good Manufacturing Practices definition

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.

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Current Good Manufacturing Practices or “cGMP” means the regulations set forth in 21 C.F.R. Parts 210 - 211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA, and the equivalent regulations and requirements applicable in the Territory.

Current Good Manufacturing Practices or "CGMP" means the requirements for ensuring that drugs and drug products are consistently manufactured, repackaged, produced, stored and dispensed in accordance with 21 C.F.R. §§ 207, 210 and 211.

Examples of Current Good Manufacturing Practices in a sentence

• This material shall be manufactured in accordance with Current Good Manufacturing Practices and shall comply with all regulations under the Federal Food Drug and Cosmetic Act and with any applicable state statutes and regulations.

• Supplier will provide Stryker with access to its manufacturing facilities in order that Stryker may make Current Good Manufacturing Practices or other required audits at such times as Stryker shall deem necessary, upon not less than forty-eight (48) hours’ notice.

• Diametrics shall retain records of any safety, quality and reliability related data relating to the Portal Measurement Products as well as any data necessary for "Current Good Manufacturing Practices" (CGMP, as required by FDA), the "In Vitro Diagnostics Directive" (the IVDD, as required by the European Union) and the "Medical Device Directive" (MDD, as required by the European Union), to the extent provided under Schedule 1, Required Quality Data.

• In addition to any other obligations set forth in this Agreement, during the Term, Valeant shall be obligated to use commercially reasonable efforts to: (i) maintain the authorization and/or ability to market the Product in the Territory to Prescribers; and (ii) ensure the consistent supply of the Product and Samples to meet market demand and Zogenix’ orders pursuant to Section 4.5 and in accordance with Current Good Manufacturing Practices and all other applicable laws.

• Each OBI facility has an FDA assigned Establishment Identification Number (FEIN) and is inspected by the FDA to evaluate Current Good Manufacturing Practices (CGMP) and compliance with relevant sections of 21 CFR 200, 600, 800 and 1200.

More Definitions of Current Good Manufacturing Practices

Current Good Manufacturing Practices or “cGMP” means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Regulatory Authority, including as promulgated under and in accordance with (i) the U.S. Federal Food, Drug and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations, Parts 210, 211, 600, 601 and 610, (ii) relevant EU legislation, including European Directive 2003/94/EC or national implementations of that Directive, (iii) relevant guidelines, including the EU Guidelines for Good Manufacturing Practices for Medicinal Products (Eudralex Vol. 4 and Annexes thereto), (iv) International Conference on Harmonisation Good Manufacturing Practice Guide for Active Pharmaceuticals Ingredients and (v) and any analogous set of regulations, guidelines or standards as defined, from time to time, by any relevant Regulatory Authority having jurisdiction over the development, manufacture or commercialization of the Product, as applicable, in each case as in effect as of the date such manufacturing for the Product are or were conducted.

Current Good Manufacturing Practices or “GMP” or “cGMP” means the current good manufacturing practice and standards as provided for (and as amended or updated from time to time) in applicable ICH Harmonised Tripartite Guidelines and as defined in Parts 210 and 211 of Title 21 of the CFR, as may be amended from time to time, or any successors thereto.

Current Good Manufacturing Practices means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including current good manufacturing practices and standards as provided for (and as amended or superseded from time to time) in:

Current Good Manufacturing Practices or “cGMP” means a manufacturing process that complies with 21 CFR Part 111 or 21 CFR Part 210.

Current Good Manufacturing Practices or “cGMP” means the then current requirements under all applicable Laws relating to manufacturing practices for products (including ingredients, testing, storage, handling, intermediates, and bulk products) including as set forth in ICHQ7 “cGMP for Active Pharmaceutical Ingredients” and as otherwise required by any Regulatory Authority having jurisdiction over the Facility (as such term is defined below), as the same may be updated, supplemented or amended from time to time.

Current Good Manufacturing Practices or “cGMP’s” means the requirements of the FDA with regard to the manufacture of Opioid Drugs and finished pharmaceuticals as set forth in 21 CFR 210 and 211, as amended from time to time or any equivalent law in the Territory.

Current Good Manufacturing Practices. (abbreviated “GMPs” or “cGMPs”) shall mean the standards established by the United States Food and Drug Administration (the “FDA”) for current Good Manufacturing Practices, as specified in FDA 21 C.F.R. §820 Quality Systems Regulations (or its successor provisions); the standards established in the European Council Directive 2004/27/EC of 31 March 2004 concerning medicinal products for human use, as amended (or its successor provisions); and other sections so designated by the title “Good Manufacturing Practices”; as applicable to each respective Product to be manufactured and/or supplied by SUPPLIER.