Good Manufacturing Practice or GMP

Good Manufacturing Practice or GMP. Means the then-current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act and such standards of good manufacturing practice as are required by the European Union and other organizations and governmental agencies in countries in which the Licensed Product is intended to be sold, to the extent such standards are not in contravention with United States GMP.

Good Manufacturing Practice or GMP. Shall mean current good manufacturing practice and standards as provided for (and as amended from time to time) in the "Current Good Manufacturing Practice Regulations" of the U.S. Code of Federal Regulations Title 21 (21 C.F.R. § 820), the European Community's Medical Device Directive, 93/42/EEC, and/or any other applicable laws, rules, regulations or guidance documents now or subsequently established by a governmental or regulatory authority in the country(ies) in which the Products are... manufactured and supplied, and any additions, or clarifications thereto, as well as compliance with ISO 13485:2016 and Quality System Regulations 21 CFR Part 820. View More

Good Manufacturing Practice or GMP. Means (a) the then current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act, (b) such standards of good manufacturing practice as are required by the applicable laws and regulations of countries in which the Product is intended to be sold, to the extent such standards are not inconsistent with the then current standards for the manufacture of pharmaceuticals as set forth in the FD&C Act, and (c) any quality requirements set forth in this Agreement or the Quality... Agreement attached hereto as Exhibit B. View More