Manufacturing Documents definition

Manufacturing Documents has the meaning set forth in Section 2.2.
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Manufacturing Documents means the document written by a company that defines a product they are making, or the requirements for one or more new features for an existing product, including full design details sufficient to permit commencement of the manufacturing process.
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Manufacturing Documents means all the documents required to manufacture, label, pack and test the Products.
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Examples of Manufacturing Documents in a sentence

  • Aptalis shall retain a copy of the Master Manufacturing Documents.

  • Strakan shall provide Aptalis with copies of all revised Master Manufacturing Documents on a timely basis.

  • In performing Development Services under this Agreement, Hovione will comply with all Applicable Laws and generally accepted industry standards, and any protocols, guidelines, instructions, processes and procedures referenced in the applicable Work Plan (provided the same do not violate any Applicable Laws and/or generally accepted industry standards), and the Manufacturing Documents, to the extent applicable, or mutually agreed to in writing signed by both Parties.

  • Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain the Master Manufacturing Documents, and Strakan shall supply such Master Manufacturing Documents to Aptalis.

  • CLIENT shall retain a copy of the Master Manufacturing Documents.

  • Drafts of all Manufacturing Documents and such other documents as are to be approved in writing by Client, as specified in the Quality Agreement or agreed to by the Joint Project Team, will be provided to Client for approval at least * days in advance of commencement of the first cGMP Batch or on such other schedule as the Joint Project Team agrees.

  • As between LiveWire and HD, (i) LiveWire shall own and have full responsibility for the design of Products, including all Technical Manufacturing Documents and (ii) HD shall own and have full responsibility for HD’s manufacturing processes and standard work instructions.

  • UMAN shall provide CLIENT with copies of all revised Master Manufacturing Documents on a timely basis.

  • Client will be responsible for (i) providing Hovione with such Client Background Know-How and other information as is specified in each Work Plan as to be provided by Client or such other Client Background Know-How reasonably requested by Hovione as is readily accessible to Client and necessary for Hovione to perform Services; and (ii) ensuring that such information is complete and accurate in all material respects; and (iii) reviewing and approving the Manufacturing Documents prepared by Hovione.

  • For the sake of clarity, this Section 10.2 is not intended to be a limitation of Client’s rights under Sections 9.5 or 10.3 and, without being considered Technology Transfer under this Section 10.2, Hovione will make available the Manufacturing Documents and other Development Deliverables to Client, at Client’s request.


More Definitions of Manufacturing Documents

Manufacturing Documents means the Xxxx of Materials (as defined in the Quality Agreement), Raw Materials Specifications, Standard Operating Procedures and Master Batch Record (as defined in the Quality Agreement).
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Manufacturing Documents shall have the meaning provided in Section 3.2(b).
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Manufacturing Documents has the meaning set forth in the Asset Purchase Agreement.
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Manufacturing Documents has the meaning set forth in Schedule 1.1.
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Manufacturing Documents means, collectively, the Specifications, the Xxxx of Materials, the Testing Criteria, the Quality Agreement, and such other manufacturing and quality assurance documentation setting forth the requirements in respect of the manufacture, storage, shipping, labelling, testing, supply, release and acceptance of Products hereunder.
Sample 1
Manufacturing Documents means, collectively, the Specifications, the Bill of Materials, the Testing Criteria, the Quality Agreement, and such other manufacturing and quality assurance documentation setting forth the requirements in respect of the manufacture, storage, shipping, labelling, testing, supply, release and acceptance of Products hereunder.
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Related to Manufacturing Documents

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Process means any process for—

  • Quality Agreement has the meaning set forth in Section 9.6.

  • 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.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • 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.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • API means American Petroleum Institute.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Distillery manufacturing license means a license issued in accordance with

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.