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 (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.
Examples of Good Manufacturing Practice in a sentence
All Purchased Inventory and reference standards to be transferred are, to Seller’s Knowledge, (i) manufactured and handled in accordance with current Good Manufacturing Practice (cGMP), and (ii) accompanied by available batch records, Certificates of Analysis (CoAs) and stability data in Seller’s possession or control.
More Definitions of Good Manufacturing Practice
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 as defined in 21 C.F.R. § 210 and 211, European Directive 2003/94/EC, Eudralex ▇, ▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, 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 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.
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 means the applicable then-current standards for conducting manufacturing activities for pharmaceutical products (or active pharmaceutical ingredients) as are required by any applicable Regulatory Authority in the Territory.
Good Manufacturing Practice or “GMP” shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the quality control and manufacturing of pharmaceutical products, including without limitation the CFR Title 21, ICH GMP Guidelines Q7, current step 4 version, dated 10 November 2000, as amended from time to time, national legislation implementing European Community Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use as amended by European Community Directives 2003/94/EC, the Rules Governing Medicinal Products in the European Community, Volume 4, including annexes.