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 “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.
Olive oils, refined-olive oils, and olive-pomace oils intended for trade should be packaged in containers complying with the General Principles of Food Hygiene by the Codex Alimentarius Commission (CAC/RCP 1) and shall comply with the Food and Drug Administration (FDA) 21 C.F.R. Sub Chapter B and E Parts 110 and 589 (Current Good Manufacturing Practices in Manufacturing, Packaging, or Holding of human food).
The lasagna shall be processed in accordance with Current Good Manufacturing Practices (21 CFR Part 110).
The coffee drink mixes shall be prepared and packaged in accordance with Current Good Manufacturing Practices (21 Code of Federal Regulations (CFR) Part 110).
More Definitions of Current Good Manufacturing Practices
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 or "cGMP" means: (a) the good manufacturing practices required by the FDA and set forth in the FD&C Act or FDA regulations (including without limitation 21 CFR 210 and 211), policies, or guidelines, in effect at any time during the term of this Agreement, for the manufacture and testing of pharmaceutical materials as applied to bulk pharmaceuticals or their intermediates, as applicable; and (b) the corresponding requirements of each applicable Regulatory Authority, in each case as may be further specified in the applicable Product Appendix.
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 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. (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.
Current Good Manufacturing Practices means current Good Manufacturing Practices as set forth in the FDCA and the Public Health Service Act (the “PHS Act”), and in regulations at 21 C.F.R. Parts 210, 211 and 600, as in effect at the time when any clinical trial regarding a Product is being conducted, provided, and to the extent applicable to such clinical trial, as such regulations are interpreted and enforced by the FDA, including as set forth in applicable guidance documents issued by the FDA, and in accordance with applicable, generally accepted industry standards.
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.