cGMP

cGMP. Current Good Manufacturing Practices as described by (i) 21 U.S.C. § 351(a)(2)(B) and in Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations ('C.F.R'), (ii) the supplementary requirements for biologics set forth in Parts 600 to 680 of Title 21 of the C.F.R. (as applicable), (iii) the latest FDA and International Conference on Harmonization (ICH) guidance documents pertaining to manufacturing and quality control practice, Commission Directive 2003/94/EEC of 08 October... 2003; and (iv) the EC Guide to Good Manufacturing Practice for Medicinal Licensed Products, in each case as applicable to Production, including corresponding guidance documents and any corresponding laws, rules or regulations of any applicable foreign jurisdiction, as each may be updated and amended from time to time provided that Althea shall have no obligation to Produce Client Product in compliance with any cGMP requirements other than (i)-(iv) above, except as expressly specified in the Quality Agreement. View More

cGMP. Current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC and ICH Guidance Q7A (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. WuXi AppTec's operational quality standards are defined in internal GMP policy documents.

cGMP. Shall mean current good manufacturing practices as required by the rules and regulations of the United States FDA.

cGMP. Current good manufacturing practices set forth in ICH (defined in 1.26) Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, and, as applicable, the equivalent regulations and requirements in any country in the Territory

cGMP. Means current Good Manufacturing Practice as defined in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 part II: Basic Requirements for Active Substances used as Starting Materials, and ICHQ7a – as incorporated in the Federal Register volume 66 No 186 (formerly ICHQ7a) and those sections applicable within FDA regulations found at title 21 of the Code of Federal Regulations (CFR) Parts 210, 211, 600, 601 and 610.

cGMP. The current good manufacturing practices applicable to manufacture, processing and packaging of pharmaceutical products for human use established by regulatory authorities, and applied at the site of manufacture, as amended from time to time and in effect during the term of this Supply Agreement

cGMP. Means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by FDA (or, as applicable, (i) other Authorities or (ii) the International Conference on Harmonization).

cGMP. Means those laws and regulations applicable in the U.S., U.K. and European Union, relating to the manufacture of medicinal products for human use, including, without limitation, current good manufacturing practices as specified in the ICH guidelines, including without limitation, ICH Q7A.

cGMP. The current good manufacturing practices applicable to the manufacture of the Product under this Agreement as defined in the U.S. Current Good Manufacturing Practices 21 C.F.R.

cGMP. (a) "current Good Manufacturing Practices" or "cGMP" as promulgated under U.S. Food, Drug & Cosmetics Act (21 U.S.C. §301 et seq.) and the regulations thereunder including 21 Code of Regulations chapters 210 and 211, as amended from time to time.