cGMP

cGMP. Current Good Manufacturing Practices, as defined by the FDA pursuant to applicable statutes and the regulations adopted from time to time under the authority of the United States Food, Drug and Cosmetics Act

cGMP. Means current good manufacturing practices and general biological products standards as promulgated under ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, US Federal Food Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV - rules governing medical products in the European Community 1989) in the most recent version.

cGMP. Current good manufacturing practices as defined in the United States Food and Drug Administration (FDA) rules and regulations, 21 CFR Part 211 for finished pharmaceuticals, manufactured in the USA. cGMP shall also mean current good manufacturing practices as defined in FDA's Guidance for Industry, Q7A Good Manufacturing Practice, Guidance for Active Pharmaceutical Ingredients for manufacturing of bulk Licensed Adjuvant in the USA.

cGMP. Current good manufacturing practices as defined by relevant Pharmaceutical Law and Pharmaceutical, Control Authority and Regulatory guidance in the country of Manufacturing

cGMP. Means then current Good Manufacturing Practices.

cGMP. Current good manufacturing practices as required by the rules and regulations of the applicable Regulatory Authority.

cGMP. The current good manufacturing practice regulations applicable to the Manufacture of Product as defined by the Q7A Guidance on Good Manufacturing Practices of the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH Q7A)

cGMP. The current good manufacturing practices stipulated or promulgated from time to time by the Regulatory Authorities that are applicable to the manufacture of the Device.

cGMP. Shall mean current good manufacturing practices required by the FD&C Act, and FDA Rules.

cGMP. The then current good manufacturing practices in effect from time to time as applicable to the manufacture of pharmaceutical products for human use and promulgated by Regulatory Authorities in each jurisdiction in which API or PRODUCT are processed, packaged, marketed, distributed, used or sold, including the requirements set forth in U.S. C.F.R. (Title 21, Parts 210-211 and 820) as amended from time to time and as further defined by FDA guidance documents.