cGMP

cGMP. Means Current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq. ), (b) relevant U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Parts 11, 210, 211), (c) EEC Directive 91/356/EEC of 13 June 1991, (d) the EC Guide to Good Manufacturing Practice for Medicinal Drug Products, including respective guidance documents and any comparable laws, rules or regulations of any... agreed upon foreign jurisdiction, as each may be amended from time to time. cGMP also includes adherence to any applicable PRODUCT license requirements and relevant current International Conference on Harmonization (ICH) guidance documents, and other relevant guidance documents. View More

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

cGMP. Means Current Good Manufacturing Practices as that term is defined in 21 C.F.R. § 820, and any other similar manufacturing law regulation or guidance that may be in effect in any country within the Territory, all as may be amended from time to time.

cGMP. Current good manufacturing practices as described in parts 210 and 211 of Title 21 of the U.S. Code of Federal Regulations, as may be amended from time to time, or any successor thereto, and any comparable laws, rules or regulations under Applicable Law;

cGMP. Or "GMP" means FDA current Good Manufacturing Practices as in effect at any given time, based on statutory authority and presently set forth as regulations in Parts 210 and 211 of the United States Code of Federal Regulations and all applicable FDA rules, regulations, guides and guidances, as amended from time to time and in effect during the Term.

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).