cGMPs

cGMPs. Means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products. For purposes of this Supply Agreement, cGMPs shall mean (i) the principles detailed in the People's Republic of China SFDA Regulation No. 9 issued by the SFDA on 18 June 1999, ICH Q7a, U.S. cGMP 21CFR Parts 210 & 211 and The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal... Products as each may be amended from time to time or (ii) legislation or regulations or guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines) promulgated by any Regulatory Authority having jurisdiction over the Manufacture of the Products, subject to any arrangements, additions or clarifications agreed to from time to time by the parties. View More

cGMPs. Means the then-current Good Manufacturing Practices applicable to the manufacture, processing, packaging, testing and release of bulk pharmaceutical products for human use, established by regulatory authorities within any relevant jurisdiction of the European Union, United States and Canada.

cGMPs. Means the current good manufacturing practices in each Territory, as may be amended or supplemented from time to time, including the current good manufacturing practices required by the FDA pursuant to 21 CFR Parts 210 and 211 and ICH Q7, each as amended from time to time.

cGMPs. The current Good Manufacturing Practices for Finished Pharmaceuticals pursuant to 21 C.F.R.210 et seq., as amended from time to time

cGMPs. Those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA in accordance with FDA regulations, guidelines, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended and in effect from time to time.

cGMPs. The current Good Manufacturing Practices promulgated by the FDA, as they may be amended from time to time.

cGMPs. Means the most recently enacted provisions of 21 CFR 211, 21 CFR 801, 21 CFR 803, 21 CFR 806, 21 CFR 807, 21 CFR 810 and 21 CFR 820 (or their successor provisions), and all sections and subparts thereof.

cGMPs. The current Good Manufacturing Practices as defined in regulations promulgated by the FDA under the Act and as generally understood and interpreted by the pharmaceutical industry

cGMPs. The then current Good Manufacturing Practices as defined in parts 210 and 211 of Title 21 of the Regulations

cGMPs. Means all applicable standards relating to manufacturing practices for bulk excipients, including U.S. Pharmacopoeia <1078> and ICH Guidelines.