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 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. (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
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, 21 CFR, Part 210.
Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR, Part 211.
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 Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product.
SuperGen shall ensure that the development activities it undertakes pursuant to Article 3 and Article 4 hereof shall be carried out in accordance with Current Good Clinical Practice, Current Good Laboratory Practice and Current Good Manufacturing Practice.
More Definitions of Current Good Manufacturing Practice
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 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 or “cGMP” means current practices for the Manufacture of Products required:
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 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 means current Good Manufacturing Practices to the extent applicable to Product (i) as defined in Parts 210 and 211 of Title 21 of the CFR, as may be amended from time to time, or any successor thereto, and (ii) as required by applicable guidelines in countries other than the United States.
Current Good Manufacturing Practice or “cGMP” means the then-current standards for the manufacture of pharmaceutical products, pursuant to (a) the FD&C Act (21 U.S.C. 321 et seq.); (b) relevant United States regulations in Title 21 of the United States Code of Federal Regulations (including Parts 11, 210, and 211); (c) EC Directive 2003/94 EC of October 8, 2003; (d) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products; (e) the International Conference on Harmonization (ICH) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; (f) any Japanese laws, rules, guidelines, or regulations corresponding to the subject matter of the foregoing; and (g) all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing.