cGMP

cGMP. Shall mean current Good Manufacturing Practice as defined in Parts 210 and 211 of Title 21 of the Code of Federal Regulations.

cGMP. Means current good manufacturing practice promulgated by the FDA, including, without limitation, the Act, 21 C.F.R. Parts 210 and 211, and all applicable FDA rules, regulations, policies and guidelines in effect at a given time.

cGMP. Means current good manufacturing practices established under the FDCA and the regulations promulgated thereunder; and other comparable laws and regulations of any competent Regulatory Authorities applicable to manufacturing activities or the Facility for the Product and Pipeline Products, all as amended from time to time.

cGMP. Shall mean the current Good Manufacturing Practices regulations promulgated by the FDA under the Act as of the time of manufacture of the applicable Commercial Products, as well as comparable good manufacturing practice regulations of any other applicable Governmental Authority of a jurisdiction in which Commercial Products are sold and subject to any arrangements, additions, or clarifications agreed from time to time between the parties.

cGMP. 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 Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess, as established through FDA regulations (including, but not limited to, 21 C.F.R. Parts 210-211), FDA guidance and FDA current review and... inspection standards and current industry standards. View More

cGMP. Shall mean current Good Manufacturing Practice as promulgated under and in accordance with the U.S. Federal Food, Drug, and Cosmetic Act, Title 21 of the U.S. Code of Federal Regulations Parts 210 and 211, as such may be amended from time to time, or any successor thereto.

cGMP. Current good manufacturing practices, as defined in the ACT.

cGMP. Shall mean current good manufacturing practices as defined from time to time (a) in regulations promulgated under the FDCA; (b) the principles and guidelines specified in Chapter II of European Commission Directive 91/356/EEC, including "the rules governing medicinal products" in the European Union Volume 4; and (c) laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture equivalent to those in (a) and (b) above.

cGMP. Means current good manufacturing practice and standards as provided for (and as amended from time to time) in the European Community Directive 91/356/EEC (Principles and guidelines of good manufacturing practice for medicinal products) and the Current Good Manufacturing Practice Regulations to the US Code of Federal Regulations, Title 21 (21 CFR 210 and 211) in relation to the production of pharmaceutical intermediates and active pharmaceutical ingredients, as interpreted by ICH Harmonized... Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7, and subject to any arrangement, additions or clarifications agreed from time to time between the Parties in the Quality Agreement. View More

cGMP. Means the current good manufacturing practices applicable to the Manufacture of the API pursuant to laws, regulations and guidelines issued by the Authorities, as amended from time to time.