cGMP

cGMP. Means "current Good Manufacturing Practices" as defined and in effect from time to time in regulations and guidelines promulgated by the FDA under the FDCA, all regulations promulgated thereunder governing the manufacture and testing of Product in the U.S., and any other laws, regulations, and guidelines applicable to the manufacture and testing of Product in the Territory, but only where RCC has authorized reference of its Drug Master File for Product.

cGMP. Means current Good Manufacturing Practices, as established by the FDA or its foreign equivalent.

cGMP. Current Good Manufacturing Practices as promulgated under each of the following as in effect on the date of this Agreement and as amended or revised thereafter

cGMP. Current Good Manufacturing Practices as promulgated under each of the following as in effect upon the Effective Date and as amended or revised thereafter: (a) the FDA Act, including 21 CFR (parts 11, 210 and 211) and other FDA regulations, policies and guidelines in effect from time to time governing the manufacture, testing and quality control of investigational drugs; and (b) all International Conference on Harmonisation (ICH) guidance documents as appropriate, including ICH guidance Q7a,... "ICH Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients," as applied to investigational drugs (Section 19) specifically for manufacturing activities of API. View More

cGMP. All laws, regulations and standards relating to the Packaging and storage of the Products and the storage of the Packaged Products (domestic or foreign), including but not limited to, the FDA current Good Manufacturing Practices, as set forth in the Title 21 of the United States Code of Federal Regulations and the EEC Good Manufacturing Guidelines, Volume IV, (and in European Community Directive 91/356/EEC) as such Regulations and Guidelines may be revised from time to time, as interpreted by... the ICH Guideline, and any other applicable laws, guidelines and regulations. In the event of a conflict between the FDA and the EEC standards, Sharp shall adhere to the more stringent standard so the Packaged Product may be distributed in either territory. View More

cGMP. All the laws, regulations and standards relating to the manufacture of the Product, Packaged Product and the Packaging (domestic or foreign), including but not limited to, the FDA current Good Manufacturing Practices, as set forth in the Title 21 of the United States Code of Federal Regulations as such Regulations and Guidelines may be revised from time to time, and any other applicable laws, guidelines and regulations. API agrees to consider adhering to more stringent EEC standards... specifically identified to API by Purchaser so the Packaged Product may be distributed outside of the United States View More

cGMP. The current Good Manufacturing Practices required by the FDA or other Regulatory Authorities as defined in Section 1.20 and set forth in the FD&C Act or FDA Regulations (including without limitation 21 CFR Parts 210, 211 and 600), policies or guidelines, effective as of the date of the Production of a Batch, for the Production and testing of pharmaceutical materials as applied solely to Bulk Drug Substance.

cGMP. The principles detailed in the US Current Good Manufacturing Practices (21 CFR 200, 211 and 600), the "Rules Governing Medicinal Product in The European Community - Volume IV Good Manufacturing Practice for Medicinal Products," and/or "Cooperative Manufacturing Arrangements for Licensed Biologics" FDA-CBER

cGMP. Means Current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the FDCA.

cGMP. The current European Guidelines, ICH Guidelines and United States Good Manufacturing Practices for Finished Pharmaceuticals pursuant to 21 C.F.R. 210 et seq., as amended from time to time.