Certificate of Analysis and Compliance definition

Certificate of Analysis and Compliance means a document in the form set forth in Exhibit A (as may be changed from time to time with the mutual agreement of the Parties), signed by ALLERGAN's designated quality manager and provided by ALLERGAN to GSK, that sets forth the analytical test results against the Specifications for a specified Lot of Product and that certifies that each batch or Lot of Product was produced and tested in compliance with the Specifications, cGMPs, the master batch record and all applicable Marketing Authorizations and Manufacturing Authorizations.
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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.

  • Column 7 will automatically calculate to reflect the total number of resident children in the LEA.Column 8 - Public - Resident Children from Low-income Families Enter, by attendance center area, the number of children from Column 5 that are from low-income families.

  • 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.

  • 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.


More Definitions of Certificate of Analysis and Compliance

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 * CONFIDENTIAL TREATMENT REQUESTED 70 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.
Sample 1
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 a certificate issued in terms of the Regulations in respect of an electrical installation or part of an electrical installation by an accredited person;

  • 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.

  • Annual Statement of Compliance As defined in Section 3.13.

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • 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.

  • 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 have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Goods Specification means any specification for the Goods, including any related plans and drawings, as set out in the Order or otherwise agreed in writing by Get Living 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.

  • 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;