Good Manufacturing Practices

Good Manufacturing Practices. The meaning set forth in the Act and the corresponding EU Directives.

Good Manufacturing Practices. Current good manufacturing practices, as specified in regulations promulgated from time to time by the FDA in its Quality System Regulations, and comparable regulations by other international Regulatory Authorities (e.g., EMA) for the manufacture and testing of pharmaceutical products.

Good Manufacturing Practices. The then-current good manufacturing practices required by the FDA, as set forth in the Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the United States.

Good Manufacturing Practices. The then-current standards for the manufacture of pharmaceutical Products as set forth in the FD&C Act and applicable regulations promulgated thereunder.

Good Manufacturing Practices. Current and any future good manufacturing practices and quality system regulations set forth by any applicable regulatory authority of a country in which the Product or the Finished Products shall be respectively manufactured or sold

Good Manufacturing Practices. Shall mean good manufacturing practices and quality system regulations set forth by any Regulatory Authority of a country in which the Finished Products shall be manufactured or sold, and if the Product is manufactured outside of the Territory, the good manufacturing practices and quality system regulations in the country in which the Product is manufactured; all as updated, amended and revised from time to time.

Good Manufacturing Practices. Current and any future good manufacturing practices and quality system regulations set forth by the United States Food and Drug Administration ('USFDA'), and if the Approved Product is manufactured or sold outside of the Unites States, the current and any future good manufacturing practices and quality system regulations set forth by the USFDA or higher standards if and as applicable in the country in which the Approved Product is manufactured or sold.

Good Manufacturing Practices. With respect to the United States, the minimum then-current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the FDCA for safety and has the identity and strength and meets the quality and purity characteristics, specified in 21 C.F.R. Parts 210 and 211, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in... such other country or jurisdiction. View More

Good Manufacturing Practices. The applicable current good manufacturing practices promulgated from time to time by the FDA in accordance with the Act