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 or “GMP” means (a) the then-current regulatory requirements for good manufacturing practices promulgated by the FDA under the FD&C 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 (b) comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials elsewhere in the Territory.
Good Manufacturing Practice means a system for ensuring that

Examples of Good Manufacturing Practice in a sentence

  • All manufacturing facilities will comply with Current Good Manufacturing Practice requirements.

  • Good Manufacturing Practice is concerned with both production and quality control.

  • Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.

  • Certificate of Good Manufacturing Practice (CGMP) or TUV or ISO or its equivalent for equipment only.

  • 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.


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 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 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 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 or “GMP” - manufacture in accordance with:
Good Manufacturing Practice means current good manufacturing practices, as set forth in the Quality System Regulation, 21 C.F.R. Part 820 and the international quality system standards for medical devices as issued by the International Organization for Standardization (ISO) (ISO13485:2003 and ISO13488: 1996).
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;