Good Manufacturing Practices

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

Good Manufacturing Practices. Or "CGMP" means the applicable provisions of guidance for API so designated by the title "Good Manufacturing Practices" or "Current Good Manufacturing Practices" promulgated under the Federal Food, Drug and Cosmetic Act or successors thereto.

Good Manufacturing Practices. Means the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the Federal Food, Drug and Cosmetic Act of 1938, as amended, as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. Good Manufacturing Practices are established through FDA regulations (including 21... CFR Parts 210-211), FDA guidance, FDA current review and inspection standards, and current industry standards. View More

Good Manufacturing Practices. Shall mean current good manufacturing practices that are applicable to the Product and the Processing thereof, as defined in 21 C.F.R. Parts 210 and 211, as amended from time to time, and regulations governed by the European Union (EU).

Good Manufacturing Practices. The current standards for manufacture, as set forth in the Act and applicable regulations and guidelines promulgated thereunder or successors thereto, as shall be in effect from time to time during the Term.

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