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.
Current Good Manufacturing Practices or “cGMPs” shall mean the good manufacturing practices required by the FDA (and set out in the FD&C Act or FDA regulations, as they may be amended from time to time (including, without limitation, 21 CFR 210 and 211), and other applicable Governmental or Regulatory Authorities as mutually agreed by the parties in writing, laws, policies, guidelines or guidance in effect at any time during the Term, for the manufacture and testing of biopharmaceutical materials as applied solely to ARIKACE.
Current Good Manufacturing Practices or “cGMP” means at any time the quality systems and good manufacturing practices as set forth in 21 C.F.R. (Parts 210 and 211) and any other Applicable Laws, directives, rules, regulations, guides and guidance in existence in the Territory at that time.

Examples of Current Good Manufacturing Practices in a sentence

  • The manufacture of the Procleix® Ultrio Elite Assay is performed in accordance with Current Good Manufacturing Practices (CGMP) in an environmentally controlled facility.

  • Adherence to Current Good Manufacturing Practices in line with the DRAP regulations (to be evaluated by the ESSI expert/s, Noncompliance to cGMP shall lead to disqualification of the relevant section or firm).iii.

  • Adequate availability of equipment / instruments in QC labs performing relevant official tests as well as compliance to Good laboratory practices (GLP) in all Labs and Current Good Manufacturing Practices (cGMP) throughout the production facility.


More Definitions of Current Good Manufacturing Practices

Current Good Manufacturing Practices or “cGMP” means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug or API to assure that such drug or API meets the regulatory requirements of the FDA and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research and the European Commission Directive 2003/94/EC of October 8, 2003.
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.
Current Good Manufacturing Practices means the then-current standards for manufacturing activities for biological or therapeutic products, as appropriate, as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practice as are required by other Governmental Authorities in countries in which Agreement Products are intended to be manufactured or sold.
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 Harmonized 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 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 “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 or “cGMPs” mean all applicable Laws in the Territory relating to manufacturing practices of medicinal products for human use promulgated by any relevant governmental authority, as may be updated, supplemented or amended from time to time. ​