Certificate of Manufacture definition

Certificate of Manufacture means a document identified as such and provided by ENDOCEUTICS to AMAG that certifies that each lot of PRODUCT was Manufactured and tested in compliance with Specifications, cGMPs, the executed Master Batch Records and other applicable regulatory documents. Certificate of Manufacture and Certificate of Analysis are provided as a single document.
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Certificate of Manufacture means (a) a certificate issued by a vendor to a distributor or importer, which certificate (i) attests that a specific lot or batch of drug has been produced in accordance with its master production documents, (ii) includes a detailed summary of current batch documentation, with reference to respective dates of revision, manufacture and packaging, and (iii) is signed and dated by the quality assurance department of such vendor; or (b) such other consistent, but more detailed definition as provided in the Quality Policy Manual.
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Certificate of Manufacture. Certificate of Manufacture shall mean a certificate issued by Contractor stating that a batch has been Processed and/or Packaged in accordance with registration documents and in conformity with GMPs.
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Examples of Certificate of Manufacture in a sentence

  • Certificate of Manufacture When inspection is waived or when the County so requires, the Contractor shall furnish to him authoritative evidence in the form of Certificates of Manufacture that the materials to be used in the work have been manufactured and tested in conformity with the Contract Documents.

  • At the time of delivery of the Items, but in no event later than thirty (30) days after each calendar quarter, Supplier will provide said documents accompanied by a completed Certificate of Delivery of Imported Merchandise or Certificate of Manufacture and Delivery of Imported Merchandise (Customs Form 331) as promulgated pursuant to 00 XXX 000, or successor regulations.

  • Certificate of Manufacture: Contractor shall furnish Consultant authoritative evidence in the form of Certificate of Manufacture that the materials to be used in the work have been manufactured and tested in conformity with the Contract Documents.

  • When inspection is waived or when the Engineer so requires, the Contractor shall furnish to him authoritative evidence in the form of Certificate of Manufacture that the materials to be used in the work have been manufactured and tested in conformity with the Contract Documents.

  • Serbian institutions developed a large body of new legislation in compliance with the European Union which has improved the business environment and functioning of the financial system.

  • Enterprise files uploaded by clients are leaf nodes of the directory structure, and they have a node attribute to point to encrypted objects in the Swift.

  • Every person desiring to obtain a Certificate of Manufacture for preparation or organic fertilizer or biofertiliser shall make an application in Form D, in duplicate, together with a fee prescribed therefore under clause 36, to Registering authority.

  • The manufacturer must show evidence that the company is licensed to manufacture food products and that the sale of the product does not constitute a contravention of the laws of that country, i.e. Free Sale Certificate (Certificate of Manufacture and Free Sale).

  • If unknown, you must indicate this information is unknown and cannot be determined using commercially reasonable methods of inquiry.As a result, we ask you to complete the attached "Certificate of Manufacture." BidderPLEASE USE BLACK INK OR TYPEWRITER WHEN PREPARING YOUR BID.

  • This data will be provided to Applied within thirty (30) days after the end of each calendar quarter and shall be accompanied by a completed Certificate of Delivery of Imported Merchandise or Certificate of Manufacture and Delivery of Imported Merchandise (Customs Form 331) as promulgated pursuant to U.


More Definitions of Certificate of Manufacture

Certificate of Manufacture will mean a document identified as such and provided by Patheon to XenoPort which attests that a specific lot of Products has been produced in accordance with the Specifications.
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Certificate of Manufacture. (CoM) is a statement that the lot of product was manufactured in accordance with cGMPs and the batch record. It lists any incident reports and investigations identified with the lot of Product and the BSE Statement for the batch. Note: Contents of CoC and CoM may be combined into one document named “Certificate of Compliance”
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Certificate of Manufacture means a document identified as such and provided by Draxis to GSK which attests that a specific lot of Products has been produced in accordance with the Specifications.
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Related to Certificate of Manufacture

  • Date of manufacture means the date on which the food becomes the product as described;

  • Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

  • 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.

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

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Mercury-added product means a product or product component that contains mercury or a mercury compound that was intentionally added;

  • API means American Petroleum Institute.

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

  • Manufacturing Process means any process for—

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Medical equipment supplier means any person, as defined in § 1-230, engaged in the delivery to the ultimate consumer, pursuant to the lawful order of a practitioner, of hypodermic syringes and needles, medicinal oxygen, Schedule VI controlled devices, those Schedule VI controlled substances with no medicinal properties that are used for the operation and cleaning of medical equipment, solutions for peritoneal dialysis, and sterile water or saline for irrigation.

  • Engine Manufacturer means CFM International, Inc.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Original equipment manufacturer means a company that manufactures products that it has designed from purchased components and sells those products under the company's brand name.

  • 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.

  • Drug store means a place whose principal business is, the

  • Modular building manufacturer means a person or corporation who owns or operates a

  • Manufacturing Site means a location where a manufacturing