Current Good Manufacturing Practice definition

Current Good Manufacturing Practice means the minimum standard for methods used in, and facilities or controls used for manufacturing, processing, packing, or holding a drug to ensure that the drug meets the requirements of the federal act as to safety, and has the identity and strength and meets the quality and purity characteristics it is represented to possess.

Current Good Manufacturing Practice means the applicable then-current standards for manufacturing of pharmaceuticals or biologicals, as set forth in the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C §§ 301, as amended from time to time, together with any similar standards of good manufacturing practice as required by CDA and other relevant Regulatory Authority.

Current Good Manufacturing Practice. (cGMP) means current Good Manufacturing Practices promulgated by the Regulatory Authorities in the jurisdictions included in Applicable Laws (as applicable to CUSTOMER and Catalent, respectively). In the European Union, this includes Directive 2003/94/EC (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended, if and as implemented in the relevant constituent country, and in the United States, this includes 21 C.F.R. Parts 210 and 211, as amended.

Examples of Current Good Manufacturing Practice in a sentence

• All products will be manufactured in a clean, sanitary environment in accordance with Title 21 CFR Part 110- Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food.

• The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR 210-211) will be the standard applied for manufacturing, processing and packing of this therapeutic product.

• Current Good Manufacturing Practice (cGMP) is the applicable term in the United States.

• With regards to any United States Pharmacopeia (USP) grade materials, Buyer agrees to (i) comply with all applicable US Food and Drug Administration (“FDA”) regulations including specifically the Current Good Manufacturing Practice (“cGMP”) regulations enforced by the FDA, and (ii) not repackage or relabel any such materials.

• Licensee shall use commercially accepted practices to ensure Current Good Manufacturing Practice is followed and that all Verified Products shall be fit for their particular purpose, be delivered free of the rightful claim of any third person by way of infringement or the like, conform to their affirmations, promises, and descriptions, be good and merchantable quality, be free from all material defects, and be free from any materials or substances that may be harmful or dangerous to human beings.

More Definitions of Current Good Manufacturing Practice

Current Good Manufacturing Practice or “cGMP” means current practices for the Manufacture of Products required:

Current Good Manufacturing Practice or “cGMP” means, at any given time, the current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practice as are required by the applicable laws and regulations of countries in which Products are intended to be sold, to the extent such standards are not inconsistent with GMP under the FD&C Act.

Current Good Manufacturing Practice or “cGMP” means all applicable standards relating to current good manufacturing practice for fine chemicals, intermediates, active pharmaceutical ingredients, bulk products and/or finished pharmaceutical/medical device products (as appropriate) required by:

Current Good Manufacturing Practice means manufacture in accordance with: (i) EC Directive 91/456/EEC, as may be amended from time to time; (ii) the current principles and guidelines of Good Manufacturing Practice for medicinal products for human use as required by, but not limited to, the applicable sections of the US Federal Food, Drug and Cosmetic Act, the US Public Health Service Act, the US Code of Federal Regulations, Title 21, Parts 210 (CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL) and 211 (CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS), and relevant final FDA Guidance and Points to Consider for drugs and/or biotechnology-derived products, as amended from time to time; or (iii) the equivalent current law or regulation in any market.

Current Good Manufacturing Practice or “cGMP” means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the regulatory requirements of the United States Food and Drug Administration and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the Center for Drug Evaluation and Research (“CDER”) and the Center for Biologics Evaluation and Research (“CBER”), and the European Commission Directive 2003/94/EC of October 8, 2003.

Current Good Manufacturing Practice or “cGMP” means, at any given time, the current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practice as are required by the applicable laws and regulations of the United States, the European Union and any other countries agreed by the Parties in writing or pursuant to the Quality Agreement, to the extent such standards are not inconsistent with cGMP under the FD&C Act.

Current Good Manufacturing Practice means manufacture in accordance with: