Good Manufacturing Practices definition

Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

Good Manufacturing Practices means the then-current standards, practices and procedures for the manufacture of drugs or medical devices, as applicable to the Licensed Products (including the practices of and methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, sterilizing, labeling, testing or holding of the Licensed Products), as promulgated or endorsed by the FDA and other applicable Governmental Authorities, including, as applicable, as set forth in 21 C.F.R. Parts 210, 211, and 820, or as otherwise required by applicable Law.

Examples of Good Manufacturing Practices in a sentence

• None of the vaccine development projects moved to the clinical trial stage owing to the lack of an approved facility for preclinical efficacy studies and lack of funding from STI during the year under review.The approval process for the CLARF to perform preclinical efficacy studies was initiated however, there was no Good Manufacturing Practices (GMP) facility for the production of human vaccines in the country.

• The product is not expected to cause any contravention to the Framework Regulation since the subsequent stages of manufacture, processing and distribution of the end article are in line with the Good Manufacturing Practices (GMP) applicable to food contact materials and article's supply chain, as listed in Regulation (EC) No 2023/2006.

• Notwithstanding the foregoing, the Commission and the Participating Member States shall use Best Reasonable Efforts, within the framework of their competencies, to support AstraZeneca in providing accelerated quality and current Good Manufacturing Practices facility approvals and OMCL testing if the requirements of safety, quality and efficacy of the Vaccine allow it to do so and are fully met.

More Definitions of Good Manufacturing Practices

Good Manufacturing Practices or “GMP” means, as to the United States and the European Union, applicable good manufacturing practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices as then in effect in the United States or the European Union.

Good Manufacturing Practices means the then-current standards for good manufacturing practices for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidance promulgated thereunder, including the Code of Federal Regulations, as amended from time to time, or under any other Applicable Laws.

Good Manufacturing Practices or “GMP” means the regulations set forth in 21 C.F.R. Parts 210–211, and the requirements thereunder imposed by the FDA, and, as applicable, any similar or equivalent regulations and requirements in jurisdictions outside the United States.

Good Manufacturing Practices means the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.

Good Manufacturing Practices or “cGMP” shall mean the current good manufacturing practices for manufacturing finished products and active pharmaceutical ingredients as set forth in the FD&C Act, their attendant rules and regulations, and any other current good manufacturing practices which are applicable to the Facility.

Good Manufacturing Practices means the requirements set forth in the quality systems regulations for medical devices contained in 21 C.F.R. Part 820.

Good Manufacturing Practices means with respect to the Company, the standards for the manufacture, processing, packaging, testing, transportation, handling and holding of Company Products, as set forth in applicable Law.