Good Manufacturing Practices definition

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

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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.

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.

Examples of Good Manufacturing Practices in a sentence

The Product Candidates are being, and since January 1, 2024, have been, developed, processed, tested, labeled, manufactured, imported, exported, stored, and distributed, as applicable, in all material respects with all Health Care Laws, including Good Manufacturing Practices and Good Tissue Practices.
All design, development and manufacturing operations performed by or on behalf of Seller are being conducted in material compliance with the Quality Systems Regulations of the FDA (21 C.F.R. Part 820), Good Manufacturing Practices at 21 C.F.R. 210, 211, and, to the extent applicable to Seller, counterpart regulations in the European Union and all other countries where compliance is required.
If pursuant to any audit and/or inspection hereunder, T▇▇▇ notifies IPC of any deviations from any Product Approvals (including NOC commitments), Specifications or Good Manufacturing Practices, then IPC shall develop a plan of action to correct such deficiencies that is acceptable to Taro and shall promptly carry out such plan at its own expense.
IPC is responsible for conducting full quality assurance investigations per IPC’s standard operating procedures, which shall at least be reasonable and consistent with Good Manufacturing Practices, for any Product found not to conform with the Specifications.

More Definitions of Good Manufacturing Practices

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 standards for good manufacturing practices for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidances promulgated thereunder, including the Code of Federal Regulations, and the guidelines of the International Conference on Harmonization and other comparable regulations and guidances of any Regulatory Authority in any country or region outside of the United States, as applicable.

Good Manufacturing Practices or “GMPs” shall mean the applicable then-current Good Manufacturing Practices as such term or its equivalent is defined from time to time by the United States Food and Drug Administration or other relevant Regulatory Authority having jurisdiction over the Development, Manufacture or Commercialization of Product in the Territory pursuant to its regulations, guidelines or otherwise, as applicable.

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 “GMP” shall mean regulations and published guidelines related to current good manufacturing practices that relate to the testing, manufacturing, processing, packaging, holding or distribution of drug or biologic drug substances and finished drugs or biologics as set forth in the EU GMP Guide on good manufacturing practices for medicinal products for human use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively, as amended during the Term of this Agreement;

Good Manufacturing Practices or “GMP” means all applicable Good Manufacturing Practices including, (i) those standards required by the MHLW, (ii) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601 and 610, (iii) the principles detailed in the ICH Q7A guidelines, and (iv) the equivalent Laws in any relevant country, each as may be amended and applicable from time to time.

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.