Good Manufacturing Practice definition

Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.
Good Manufacturing Practice means a system for ensuring that
Good Manufacturing Practice or “GMP” means the then-current good manufacturing practice standards applicable to the Manufacturing of a Compound or Product under Applicable Law, including 21 C.F.R. parts 210 and 211 and all applicable FDA rules, regulations, orders and guidances.

Examples of Good Manufacturing Practice in a sentence

  • An AMS plant survey audit verifies that, at the time of the survey, the manufacturer produces products in a clean sanitary environment in accordance with Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110).

  • An AMS PSA verifies the manufacturer's capability to produce products in a clean sanitary environment in accordance with Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110), and verifies that the manufacturer has in place an internal quality assurance program.

  • The plant survey audit verifies that, at the time of the survey, the manufacturer produces products in a clean, sanitary environment in accordance with CGMP (21 CFR Part 110) or the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (21 CFR Part 117) in effect on the date of the solicitation, contract, or purchase order, and as applicable to the production facility.

  • The plant survey audit verifies that, at the time of the survey, the manufacturer produces products in a clean, sanitary environment in accordance with Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117).

  • Manufacturing firms of the supplied items shall adhere to the most updated regulations under the Federal Food, Drug, and Cosmetic Act, embodied in "Drugs: Current Good Manufacturing Practice in manufacture, processing, packaging, or holding"; and Part 210 and 211, Title 21 Code of Federal Regulations, Food and Drugs.


More Definitions of Good Manufacturing Practice

Good Manufacturing Practice means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use as defined in 21 C.F.R. § 210 and 211, European Directive 2003/94/EC, Eudralex 0, Xxxxx 00, xxx xxxxxxxxxx Xxxxxx Xxxxxx, European Union, and ICH Guidance and/or regulatory requirements for a product.
Good Manufacturing Practice means all applicable principles and guidelines for good manufacturing practice for drugs and medicinal products, as such principles and guidelines are amended, implemented and supplemented from time-to-time, including without limitation as specified in the applicable provisions of (i) European Directive 2003/94/EC and further guidance as published by the European Commission in Volume IV of “The rules governing medicinal products in the European Community” and (ii) Title 21 Parts 210 and 211 of the US Code of Federal Regulations (21 CFR, parts 210 and 211).
Good Manufacturing Practice means any applicable Law, guidance of any Governmental Entity and prevailing industry practices concerning manufacturing practices for pharmaceutical products (and components thereof), including 21 C.F.R. Parts 210, 211.
Good Manufacturing Practice or “GMP” means the current quality assurance standards that ensure that pharmaceutical products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use as defined in 21 C.F.R. § 210 and 211, European Directive 2003/94/EC, Eudralex 4, Annex 16, and applicable United States, European Union, Canadian and ICH guidance or equivalent laws in other jurisdictions to the extent no less stringent.
Good Manufacturing Practice or "GMP" shall mean the current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time, and any other applicable manufacturing requirements under the laws, rules or regulations of the Territory.
Good Manufacturing Practice means the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use.