GMP Specifications definition

GMP Specifications means: the specifications to be agreed by SYNCO and ADVAXIS, in writing after completion of the Engineering Batch, in the relevant Service Specific Addendum and to which the Product manufactured in the Manufacturing Phase will have to conform, including any and all specifications relating to the manufacture, storage and handling of the Product.

Examples of GMP Specifications in a sentence

  • GMP Specifications & Prose Statement, dated March 14, 2018, and supplemental reference documents.

  • After acceptance by the Owner of the GMP Drawings, GMP Specifications, proposed Project Schedule, and upon written authorization by the Owner to proceed, the Contractor shall submit a Proposal for the completion of the DB Work to Owner (“DB Work Proposal”).

  • When the length of any pipe section exceeds one thousand (1,000) feet, the Engineer reserves the right to require the pipe be tested in sections, the length of which shall be determined by the Engineer.

  • ADVAXIS and SYNCO agree that any and all obligations of SYNCO under this Agreement in the Manufacturing Phase are subject to SYNCO and ADVAXIS having agreed on the GMP Specifications and the GMP Procedures and ADVAXIS having paid the Reservation Fee for the reservation of the Slot as provided in Article 5.3.

  • The Draft GMP Specifications will be attached to the applicable Service Specific Addendum.

  • Subject to Article 16.1, any Batches manufactured during the Manufacturing Phase shall on the date of delivery to ADVAXIS conform to the GMP Specifications, as described in the applicable Service Specific Addendum, and when manufacturing GMP Batches SYNCO shall conform to the GMP Procedures, as described in the applicable Service Specific Addendum in all material respects.

  • The term “Specifications” refers to the GMP Specifications and the Final Specifications collectively, or as the context may require.

  • If the Parties disagree whether Batches conform to the GMP Specifications, then the Batches in dispute will be tested and further analyzed by a qualified independent testing laboratory reasonably acceptable to both Parties.

  • The GMP Specifications will be attached to the applicable Service Specific Addendum.

  • The Parties agree that they will use their reasonable best efforts to reach an agreement on the GMP Specifications.

Related to GMP Specifications

  • 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.

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

  • Standard Specifications means a compilation in book form of specifica- tions approved for general application and repetitive use;

  • 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;

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

  • TENDER SPECIFICATIONS means the Scope of Work, Special Instructions / Conditions, Technical specifications/requirement , Appendices, Site Information and drawings pertaining to the work and any other relevant reference in the Tender Document for which the Bidder are required to submit their offer.

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

  • 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.

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

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

  • Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.

  • IS Specification means the Specification of latest edition with amendments, if any, up to time of receipt of tender by Corporation issued by the Bureau of Indian Standards as referred to in the specifications and / or work orders.

  • 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.

  • TENDER SPECIFICATION means “Specific conditions, technical specifications, appendices, site information and drawing pertaining to the work in which the tenderers are required to submit their offer. Individual specification number will be assigned to each tender specification.

  • District Specifications means the specifications followed by the State Government in the area where the work is to be executed.

  • Goods Specification means any specification for the Goods, including any related plans and drawings, as set out in the Order or otherwise agreed in writing by Get Living and the Supplier;

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

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

  • Class specification means a written description of a class setting forth factors and conditions which are essential characteristics of positions in that class.

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

  • 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;

  • District specification means the specifications followed by the State Govt. in the area where the work is to be executed.

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

  • Specification Schedule means the Schedule containing details of the Specification.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • 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.