Certificate of Analysis and Compliance definition

Certificate of Analysis and Compliance means a document as determined by mutual agreement of the Parties, signed by the designated quality manager of Indevus or Indevus’ Third Party Manufacturer, as applicable, and provided by such Person to Esprit, that sets forth the analytical test results against the Specifications for a specified Batch or lot of Finished Products and/or Samples and that certifies that each Batch or lot of Finished Products and/or Samples was produced and tested in compliance with the Specifications, cGMPs, the master Batch record and all applicable FDA Approvals.
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Certificate of Analysis and Compliance means the certificate for each Batch of BC Parenteral Meloxicam or Finished Meloxicam delivered hereunder listing the tests performed, the test specifications and the test results and certifying that such Batch was Manufactured in accordance with cGMP.
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Certificate of Analysis and Compliance means a written certification, substantially in the form attached as Exhibit A, delivered by Supplier to Purchaser with each shipment of Finished Products that (i) sets forth the analytical test results for said shipment of Finished Product, and (ii) states that the said shipment of Finished Product was manufactured in compliance with the Specifications and the GMP.
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Examples of Certificate of Analysis and Compliance in a sentence

  • The Independent Laboratory’s results of analysis, absent manifest error, shall be deemed final as to any dispute over compliance of the Finished Product in all material respects with the Certificate of Analysis and Compliance and/or any other pertinent Specifications and/or the warranties set forth in Article 13 of this Agreement.

  • Prior to the delivery of any Batch of Polymer Product, Alkermes will send to Amylin a Certificate of Analysis and Compliance for such Batch as well as, if the Parties agree, a quality control sample of such Batch (the date Alkermes sends such documents and/or materials to Amylin, the “Release Date”).

  • Delivery will not be complete unless each shipment is accompanied by a Certificate of Analysis and Compliance (as defined in this Section 14.7) and any required export documentation.

  • If the analysis of the Independent Laboratory shows that the Finished Product did not at the material time(s) conform in all material respects to the Certificate of Analysis and Compliance or any other pertinent Specifications or the warranties set forth in Article 13 of this Agreement at the time of delivery to the common carrier, the costs of such analysis shall be paid by Supplier.

  • The Certificate of Analysis and Compliance provided by Alkermes shall include the following: Batch number, Quality Signature (name, title, signature, and date signature applied, the “Quality Signature”), test, test specification and test result.

  • The ALLERGAN Senior Quality Manager shall establish procedures for providing the Certificate of Analysis and Compliance and such other information as is necessary under cGMP, the Regulatory Approvals and applicable law for GSK to make the final decision on release of Product for sale in the Territory.

  • If the analysis of the Independent Laboratory shows that the Finished Product did at the material time(s) conform in all material respects to the Certificate of Analysis and Compliance and any other pertinent Specifications and the warranties set forth in Article 13 of this Agreement at the time of delivery to the common carrier, the costs of such analysis shall be paid by Purchaser.

  • ALLERGAN shall provide GSK with a Certificate of Analysis and Compliance, which shall accompany each Lot delivered to GSK.

  • With each shipment of Finished Product, Supplier shall provide Purchaser with commercially appropriate shipping documentation (including Purchaser’s purchase order number and the quantity of the Finished Product) and with a Certificate of Analysis and Compliance identifying the applicable lot and batch numbers and indicating conformance of the shipment with the Specifications.

  • Delivery will not be complete unless each shipment is accompanied by a valid Certificate of Analysis and Compliance and any required export documentation.


More Definitions of Certificate of Analysis and Compliance

Certificate of Analysis and Compliance means the certificate for each Batch of Polymer Product delivered hereunder listing the tests performed, the test specifications and the test results and certifying that such Batch was Manufactured in accordance with cGMPs.
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Related to Certificate of Analysis and Compliance

  • 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 Compliance means the certificate referred to in Section 3.03 of the Servicing Agreement and substantially in the form of Exhibit E to the Servicing 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.

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

  • Assessment of Compliance As defined in Section 3.21.

  • Statement of Compliance means the statement forming part of a Tender indicating the Bidders compliance with the Specification.

  • 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.

  • Annual Statement of Compliance As defined in Section 3.13.

  • 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.

  • 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.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • COA means certificate of analysis.

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

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • Compliance Review means an inspection of the home, grounds, and files to determine compliance with these regulations.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • 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.

  • 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;

  • Notice of compliance means a statement confirming that a governmental entity

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • 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.

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;