Manufacturing Requirements Document definition

Manufacturing Requirements Document means a manual containing certain specifications, procedures, methods and personnel contacts relating to the manufacturing and supply of the Bulk Drug Substance by Ophidian to Lilly that will be compiled and agreed upon by the Project Team prior to the 47 commencement of manufacture of the Bulk Drug Substance by Ophidian. Sections of the Manufacturing Requirements Document may be modified from time to time by the Project Team.
Manufacturing Requirements Document means a manual containing
Manufacturing Requirements Document means a manual containing certain specifications, procedures, methods and personnel contacts relating to the manufacturing and supply of the Bulk Drug Substance as more fully described in Section 7.2 of the Agreement. Sections of the Manufacturing Requirements Document may be modified from time to time by the Project Team.

Examples of Manufacturing Requirements Document in a sentence

  • These standards apply to all health care services and are an important element in the development of a licensing system to be operated by HIQA.

  • Sometimes used interchangably with Education MRD Manufacturing Requirements Document MRD Marketing Requirements Document MRD Market Requirement Document MRK Xxxx Primitive Signal This primitive signal applies only to Arbitrated Loop topology.

Related to Manufacturing Requirements Document

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

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

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • 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.

  • Monitoring Requirements Schedule means the Schedule containing details of the monitoring arrangements.

  • Project specific information means such part of the Instructions to Consultants used to reflect specific project and assignment conditions.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • 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.

  • Service Specifications means the following documents, as applicable to the Services under Your order:

  • Compliance schedule means a schedule of events, by date, which will result in compliance with these regulations.

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • 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 Agreement has the meaning set forth in Section 2.6.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Specifications and Standards means the specifications and standards relating to the quality, quantity, capacity and other requirements for the Project Highway, as set forth in Schedule-D, and any modifications thereof, or additions thereto, as included in the design and engineering for the Project Highway submitted by the Contractor to, and expressly approved by, the Authority;

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Manufacturing Process means any process for—