Certificate(s) of Analysis definition

Certificate(s) of Analysis means a certificate indicating the Bulk Product’s conformance to the applicable Specifications, signed by a Client representative or designee and provided to PCI prior to the commencement of Packaging of such Bulk Product.
Sample 1
Certificate(s) of Analysis. At Althea's cost and expense, Xxxxxx shall test, or cause to be tested by third parties, in accordance with the Specifications each Batch of Drug Product that is Produced pursuant to this Agreement, such testing to be completed before delivery of the Batch to Altus or its designee. All results of such testing shall be recorded in a certificate of analysis in a form approved by Altus or its designee (each, a "Certificate of Analysis"). Xxxxxx shall deliver to Altus or its designee, prior to each completed Batch being delivered, the completed Certificate of Analysis for such Batch, which shall set forth the items tested and the test results. Xxxxxx shall also indicate on the final page of the Executed Release Batch Record for each Batch delivered that all batch Production and control records have been reviewed and approved by the appropriate quality control unit. Xxxxxx shall send, or cause to be sent, to Altus or its designee such Certificate of Analysis and Executed Release Batch Record for each Batch prior to the shipment of the Batch of Drug Product. Altus or its designee shall have the right to test, or cause to be tested, for final release, each Batch of Drug Product as meeting the Specifications and other requirements of this Agreement. As required by the FDA (see Section 7.2 below), Altus (or its designee, as applicable) assumes full responsibility for final release of each Batch of Drug Product.
Sample 1
Certificate(s) of Analysis means the document(s) associated with each of the Raw Materials and Containers used when each Batch is Processed, specifying the results of analytical testing (if applicable) on such Raw Materials and Containers to assure such Raw Materials and Containers meet appropriate Raw Materials and Containers Specifications.
Sample 1

Examples of Certificate(s) of Analysis in a sentence

  • Certificates of Compliance and Certificates of Analysis shall comply with the requirements specified herein, the ADOT Materials Testing Manual, and applicable ADOT Materials Policy and Procedure Directives.

  • However, as a minimum, a full analysis should be performed at appropriate intervals and compared with the Certificates of Analysis.

  • Satisfactory Certificates of Analysis have been provided for all working standards.

  • Please refer to Product Data Sheets, Certificates of Conformity or Certificates of Analysis for chemical and physical data for determinations of quality and for formulation purposes.

  • All shipments of Flexion-Supplied Materials, if required, will be accompanied by Certificate(s) of Analysis from the Material manufacturer or Flexion, confirming its compliance with the Material’s specifications.

  • No structural materials will be accepted which cannot be properly identified with Certificates of Analysis and Certificates of Compliance.

  • Reliability of Certificates of Analysis should be checked at regular intervals.7.32 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company’s control do not need to be tested if the manufacturer’s Certificate of Analysis is obtained, showing that these raw materials conform to established specifications.

  • Total compliance (10 points): Certificate(s) of Analysis (CoA), letters of guarantee or other formal documentation from the fertilizer manufacturer's or supplier(s) should be current and state any inert or active ingredient substances used as "fillers" (e.g., clay pellets, granular limestone).

  • Certificates of Analysis have been provided for any working standards used.

  • Supplier shall ensure that each shipment/delivery is accompanied by applicable Material Safety Data Sheets and Certificates of Analysis.

Related to Certificate(s) of Analysis

  • 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.

  • 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.

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

  • Sample means urine, blood, breath, saliva, or hair.

  • risk analysis the analysis required under Rule 17f-7(a)(1)(i)(A).

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • 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.

  • 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.

  • COA means certificate of analysis.

  • 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.

  • Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

  • CREFC® Operating Statement Analysis Report The monthly report in the “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.

  • MSDS means Material Safety Data Sheet.

  • API means the American Petroleum Institute.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Credential analysis means a process or service by which a third party affirms the validity of an identity document described in section 25(6)(c) through a review of public and proprietary data sources conducted remotely.

  • 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.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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.

  • 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;

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Market Analysis means a technique used to identify market characteristics for specific goods or services “National Treasury” has the meaning assigned to it in section 1 of the Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.