cGMP

cGMP. The current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.

cGMP. Current Good Manufacturing Practice as set out in the United States 21 CFR 210 and 211, as amended from time to time, together with, as applicable, any analogous regulations, codes or guidelines having effect in any jurisdiction in the Territory in which Products are to be Manufactured and/or distributed

cGMP. Means current good manufacturing practices applicable to the Manufacture of Product promulgated by any Authority.

cGMP. Means those current practices, as amended from time to time, related to the manufacture of biopharmaceuticals and pharmaceuticals as set forth in the FDCA and such standards of good manufacturing practice as are required by the FDA or other Regulatory Authorities (as defined herein), as agreed in the Project Plan and as may be set forth in the United States Code of Federal Regulations (Title 21, Parts 210-211).

cGMP. Current Good Manufacturing Practices regulations and guidelines applicable to the manufacture of pharmaceuticals and biologics intended for use in clinical trials in the United States and/or the European Union, including those described in the U.S. Food, Drug & Cosmetics Act (21 U.S.C. Section 301 et seq.) and regulations promulgated thereunder, and in ICH guide Q7a "ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," as applied to investigational drugs (Section 19).

cGMP. Current good manufacturing practices required under the United States Food, Drug and Cosmetic Act, as amended, and applicable FDA regulations, policies and guidelines, in effect at the time in question for the manufacture and testing of pharmaceutical materials. cGMP shall also encompass any local or national governmental authority requirements applicable to Gland's manufacturing and distribution of the Products to the extent such requirements do not contravene the United States Food, Drug and... Cosmetic Act and FDA regulations, policies, and guidelines View More

cGMP. Current Good Manufacturing Practices applicable to the manufacturing, processing, packaging, holding or distribution of Client Product or any intermediate thereof pursuant to Applicable Law.

cGMP. Means current Good Manufacturing Practices regulations promulgated by FDA, as they may be amended from time to time. cGMP also includes published standards of FDA (or other standards of FDA that are generally recognized within the United States pharmaceutical industry) that relate to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs. cGMP also includes similar standards, guidelines and regulations promulgated or otherwise required... by the European Commission, and published standards of the European Commission (and other standards of the European Commission that are generally recognized within the European pharmaceutical industry), including the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC, as amended from time to time, that relate to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs. View More

cGMP. Current good manufacturing practices for medicinal products established by U.S. laws, rules and regulations (including 21 CFR Parts 210 and 211, as amended, and any successor regulations thereto, each as in effect from time to time).

cGMP. The current good manufacturing practices applicable to the Manufacture of Product pursuant to Applicable Law in effect in the European Union and/or the United States of America as of the date of Manufacture of a particular Batch of Product.