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 certificate attesting that a particular Batch of Product was Processed in accordance with cGMP and the final executed Batch production and quality control records.
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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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Examples of Certificate of Manufacture in a sentence

  • 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 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.

  • 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).

  • 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.

  • Should any drawback be claimed and upon Buyer’s request, Supplier agrees to furnish a completed Certificate of Delivery or Certificate of Manufacture and Delivery and retain substantiating documentation pursuant to 19 U.S.C. Section 1313.

  • Telecom industry, with an expansive distribution network is best placed to capture this opportunity.

  • In one case, an agitator helped a worker’s family prepare the paperwork for a lawsuit that resulted in the return of their apartment.

  • For all Tositumomab provided to GSK Canada hereunder, Corixa shall provide to GSK Canada, within fifteen (15) business days of McKesson's release, (i) BI Pharma's Certificate of Analysis and Batch Certificate, (ii) McKesson's Certificate of Manufacture, and (iii) a label specimen.

  • Certificate of Manufacture When the RIOC/LiRo PM 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 Specifications.

  • In addition, for the first [***] Drug Product Manufactured at the manufacturing facilities listed in Annex 5, and for the [***] of Drug Product Manufactured at any such manufacturing facility in each Calendar Year, ENDOCEUTICS shall provide AMAG with a copy of the Certificate of Analysis, Certificate of Manufacture, executed Batch Records and testing records, in each case, at least [***] prior to the date when AMAG is required to pick up such PRODUCT.


More Definitions of Certificate of Manufacture

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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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. 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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Related to Certificate of Manufacture

  • 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.

  • 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.

  • Certificate of Catholic Practice means a certificate issued by the family’s parish priest (or the priest in charge of the church where the family attends Mass) in the form laid down by the Bishops’ Conference of England and Wales. It will be issued if the priest is satisfied that at least one Catholic parent or carer (along with the child, if he or she is over seven years old) have (except when it was impossible to do so) attended Mass on Sundays and holy days of obligation for at least five years (or, in the case of the child, since the age of seven, if shorter). It will also be issued when the practice has been continuous since being received into the Church if that occurred less than five years ago. It is expected that most Certificates will be issued on the basis of attendance. A Certificate may also be issued by the priest when attendance is interrupted by exceptional circumstances which excuse from the obligation to attend on that occasion or occasions. Further details of these circumstances can be found in the guidance issued to priests http://rcdow.org.uk/education/governors/admissions/

  • 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.

  • Certificate of origin means the document provided by the manufacturer of a new motor vehicle, or

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

  • Certificate of approval means a certificate of approval obtained from the

  • Certificate of inspection means an unsworn statement,

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

  • certificate of fitness means a certificate issued by the Department to a contract bus carrier.

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

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

  • Certificate of organization means the certificate required by section 489.201. The term includes the certificate as amended or restated.

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

  • Certificate of Completion means the certificate of completion given by the Engineer-in- charge pursuant to clause 40 of these conditions;

  • certificate of registration means registration with the College that allows the Participant to practise medicine in British Columbia, other than the certificate of registration which allowed the Participant to enrol in Postgraduate Medical Education;

  • 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

  • API means the 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.