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.
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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.
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Manufacturing Requirements Document means a manual containing
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Examples of Manufacturing Requirements Document in a sentence

  • That inspection shall be performed in accordance with the Manufacturing Requirements Document.

  • The bulk drug responsibilities will be described in a separate Manufacturing Requirements Document ("MRD") for clinical and commercial materials.

  • Additionally, a Manufacturing Requirements Document will be developed and agreed to prior to the manufacture and supply of the first Phase I Clinical Trial Product material.

  • An outline of the initial content for the Manufacturing Requirements Document is included in Appendix II.

  • As to quantities of Bulk Drug Substance in relation to which Lilly and Vertex are unable to agree as to whether they conform to the Bulk Drug Substance Specifications, the parties may submit appropriate samples of that Bulk Drug Substance to a mutually acceptable third party testing laboratory that will perform testing to determine whether the Bulk Drug Substance conforms to the Bulk Drug Substance Specifications, using the test protocols and methodology provided in the Manufacturing Requirements Document.

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

  • This Manufacturing Requirements Document ("MRD") describes certain procedures, personnel contacts and other matters relating to the manufacturing and supplying of Products by Lilly to Dura.

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 a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • 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.