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 or “GMP” means that part of quality assurance which ensures that medicinal products are consistently produced and controlled in accordance with quality standards appropriate for their intended use and as required by the applicable marketing authorisations or product specifications;

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;

Good Manufacturing Practice means current good manufacturing practices, as applicable to the manufacture of medical devices, as in effect at the relevant time, including as specified in 21 CFR Part 820 and any applicable international and foreign equivalent to the foregoing.

Good Manufacturing Practice means the current good manufacturing practice regulations of the FDA, including as described in the U.S. Code of Federal Regulations, Parts 210, 211, 601, and 606, or any applicable corresponding foreign regulations or their respective successor regulations.

Good Manufacturing Practice or “GMP” means: 1) the regulatory requirements for current good manufacturing practices promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act (as set forth at 21 C.F.R. § 210 et seq.) and under the Public Health Service Act, Biological Products (as set forth at 21 C.F.R. §§ 600-610), as the same may be amended from time to time; and 2) such standards of good manufacturing practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be manufactured or sold, to the extent such standards are not less stringent than the FDA regulatory requirements stated above.