Certificate of Analysis and Conformity definition

Certificate of Analysis and Conformity means the certificate for each batch of Product delivered with such Product listing the tests performed, the specifications for the manufacture of such Product, and the test results and certifying that such batch of Product was manufactured in accordance with applicable Law, including cGMPs, and production standard operating procedures.
Certificate of Analysis and Conformity means the certificate for each batch or lot of Product delivered hereunder in the form contemplated by Section 3.11 of this Agreement.
Certificate of Analysis and Conformity means the certificate of analysis confirming the identity, quality and purity of a Lot of Active Ingredient to which it pertains together with the certificate of conformity confirming that the same Lot of Active Ingredient was manufactured, tested, stored and supplied in compliance with the Specifications, applicable cGMPs and Applicable Laws, each such certificate signed by an authorized employee of Bachem.

Examples of Certificate of Analysis and Conformity in a sentence

  • 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.

  • Final invoices for the balance of shall be prepared by Bachem in accordance with Section 3.7. The balance shall be paid by Thera within days following receipt by Thera of each of the Certificate of Analysis and Conformity and an invoice for the Lots of Active Ingredient.

  • The terms of payment shall be net [Redacted: Term] following receipt by Thera of each of the Certificate of Analysis and Conformity, the Executed Batch Record and an invoice for the Lots of Active Ingredient.

  • Each test report shall set forth the items tested, Specifications and test results in the Certificate of Analysis and Conformity (as defined in Section 1.1.12) for each Lot.

  • If Thera Quality Assurance fails to review and confirm to Bachem the Certificates of Analysis and Conformity within that business day’s timeline, Bachem shall invoice the balance remaining for the Lot and, upon Thera’s written request, either ship the Lot of Active Ingredient or transfer the Lot of Active Ingredient to customer warehouse, a CMP controlled storage area at Bachem’s facility, until Thera’s review of the Certificate of Analysis and Conformity is complete.

  • Each test report shall set forth the items tested, Specifications and test results in the Certificate of Analysis and Conformity (as defined in Section 1.1.11) for each Lot.

Related to Certificate of Analysis and Conformity

  • Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.

  • Certificate of Conformity means Executive Order certifying vehicles for sale in California.

  • 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 set out in the Purchase Order or otherwise agreed in writing by the Customer and the Supplier;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • 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 product specification for a Medical Device set out in Schedule 2;

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • COA means certificate of analysis.

  • 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.

  • IS Specification means the Specification of latest edition with amendments, if any, up to time of receipt of tender by Corporation issued by the Bureau of Indian Standards as referred to in the specifications and / or work orders.

  • 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 A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • 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 the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • 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.

  • 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 Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.