cGMP

cGMP. Means the current Good Manufacturing Practices regulations of the FDA (as in effect from time to time) contained in 21 C.F.R. pts. 210 and 211.

cGMP. Current good manufacturing practices established under the Act and the Regulations.

cGMP. Shall mean current Good Manufacturing Practice as defined 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.

cGMP. The current good manufacturing practices established by FDA applicable to the Drug Product.

cGMP. Shall mean the current good manufacturing practices required by the FDA and set forth in the FD&C Act or FDA regulations, policies, or guidelines in effect at a particular time for the manufacture, testing and quality control of pharmaceutical materials as applied to biologics, together with any other applicable regulations, except to the extent that the standards for the manufacture, testing and quality control of pharmaceutical materials as applied to biologics, or other applicable... regulations, are higher or more stringent in any other country, state or locality in the Territory than those required by the FDA, in which case such country, state or locality's standards will apply. View More

cGMP. Shall mean current Good Manufacturing Practices as defined in regulations promulgated by the FDA under the Act and corresponding regulations in the other countries of the Territory.

cGMP. Shall mean current Good Manufacturing Practices as in effect under the Act from time to time and similar regulations in other countries under Applicable Laws.

cGMP. Means current Good Manufacturing Practices as promulgated under and in accordance with ICH Q7A GMP guidelines and the U.S. Federal Food, Drug and Cosmetic Act, 21CFR (Parts 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC, as appropriate.

cGMP. , "GMP" or "Current Good Manufacturing Practices" means the regulatory requirements for the current good manufacturing practices in the United States Code of Federal Regulations 21 CFR Part 210 & Part 211, the standards, rules, principles, and guidelines set out in the provisions of Chapter II of the EC Commission Directive 2003/94/EC, together with European Union ("EU") Volume 4 Good Manufacturing Guidelines, the MHLW GMP/GQP ordinances and applicable regulations in Japan and/or Canada, as... applicable to the manufacture of the Product, and all rules, regulations, promulgations, policies, and guidelines of other Regulatory Authorities applicable to the manufacture of the Product in the Territory in effect at any given time during the applicable Term. View More

cGMP. Shall mean the quality systems and current good manufacturing practices for the manufacture of the PRODUCT required by the REGULATORY AUTHORITIES in any country in the MAJOR MARKET, as amended from time to time.