Certificate of Analysis and Conformity Definition | Law Insider

    Alkermes shall assay and analyze such samples in accordance with the Specifications and shall prepare a Certificate of Analysis and Conformity that shall be delivered to Cephalon.

  • Certificate of Analysis means a document prepared by Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results.

  • Certificate of Conformity means a document issued by the Supplier to the Buyer stating that the Deliverables are in conformity with the requirements of the Agreement.

  • Certificate of Conformance means a document issued by the NCWM based on testing by a participating laboratory that constitutes evidence of conformance of a type.

  • Batch Record means the production record pertaining to a Batch.

  • Goods Specification means any specification for the Goods, including any related plans and drawings, that is agreed in writing by the University and the Supplier.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

  • Product Specification means a file attached to the application for the protection of a geographical indication, in which the specifications with which the spirit drink has to comply are set out, and which was referred to as a ‘technical file’ under Regulation (EC) No 110/2008;

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • COA means Committee on Accreditation of the American Psychological Association.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time. The Contract Specifications appear on the Website.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

  • Material safety data sheet or “MSDS” means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Technical Specifications means the technical specifications set forth in Schedule 1 to the Agreement and to which, the STBs, CAS and SMS must comply with.

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CE marking of conformity or ‘CE marking’ means a marking by which the manufacturer indicates that the device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

  • Nonconformity or “Nonconformities” means any failure or failures of the Software to conform to the requirements of this Contract, including any applicable Documentation.

  • Product Specifications means those manufacturing, materials, packaging, labeling, testing, and performance specifications for the Product filed with the relevant Regulatory Authority, required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Exhibit 1.25 which specifications may be amended by the parties from time to time in accordance with this Agreement.

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

  • Detailed Specifications means the specifications for materials and works as specified in PWD BSR/ issued under the authority of PWD/ or as implied/added to or superseded by the special conditions.

  • District specification means the specifications followed by the State Govt. in the area where the work is to be executed.

  • Project specific information means such part of the Instructions to Consultants used to reflect specific project and assignment conditions.

  • TENDER SPECIFICATION means “Specific conditions, technical specifications, appendices, site information and drawing pertaining to the work in which the tenderers are required to submit their offer. Individual specification number will be assigned to each tender specification.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.