cGMPs

cGMPs. Means current good manufacturing practices for the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, packing and holding of pharmaceutical excipients, all as set forth from time to time by the U.S. Pharmacopoeia General Chapter <1078> Good Manufacturing Practices For Bulk Pharmaceutical Excipients and International Pharmaceutical Excipients Council's IPEC/PQG GMP Guide For Pharmaceutical Excipients, and any successors thereto.

cGMPs. The current good manufacturing practices and standards for the production of pharmaceutical intermediates and active pharmaceutical ingredients applicable to both commercial and investigational quantities of compounds (as applicable)

cGMPs. Current good manufacturing practices, as specified in Applicable Law of the Territory, applicable to the manufacture of Bulk Drug Product for use in the Territory

cGMPs. The then-current good manufacturing practices and standards for the production, manufacture, testing, handling and storage of pharmaceutical intermediates and active pharmaceutical ingredients applicable to both commercial and investigational quantities of compounds (as applicable), as set forth in: (a) Parts 210 and 211 of Title 21 of the U.S. Code of Federal Regulations (21 CFR 210 and 21 CFR 211); and (b) European Community Directive 2003/94/EC and the Rules Governing Medicinal Products in... the European Union, Volume 4 (Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice); in each case, as may be amended from time to time after the Effective Date, and as interpreted by ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. View More