Drug Product Specifications definition

Drug Product Specifications means the Specifications for the Active Drug Product or Diluent, as applicable, the current versions of which (as of the Effective Date) are set forth in Schedule 2B attached hereto.
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Drug Product Specifications means specifications developed by Immunex and Wyeth as set forth in the Product BLA that describe testing methods and acceptance criteria for Drug Product, as well as in-process specifications, and which are attached hereto as EXHIBIT B, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be required to obtain approval of the Drug Product from the FDA, EMEA and other regulatory authorities in the Territory. BIP shall not unreasonably withhold its agreement to such specification amendments after agreement of the Parties on the commercial impact of any such amendments.
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Drug Product Specifications means the specifications, characteristics, properties and performance requirements of the Drug Product, adapted for aerosolization and delivery by the Inhaler, which are set forth in Exhibit B, including, without limitation, any characteristics or parameters which specify: (a) the Formulation; or (b) the percentage of pulmonary deposition, particle/droplet size for the Drug Product, absorption, the stability of the Drug Product or aerosol characteristics.
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Examples of Drug Product Specifications in a sentence

  • In the event CLIENT shall be required to recall any Drug Product because such Drug Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Drug Product Specifications, or in the event that CLIENT elects to institute a voluntary recall, CLIENT shall be responsible for coordinating such recall.

  • When CUMBERLAND seeks to change the Drug Product Specifications, such change shall be incorporated within the Specifications only with the prior written consent of FAULDING, such consent not to be unreasonably withheld or delayed.

  • Within sixty (60) calendar days after receipt by CLIENT of the samples of the Batch and the Released Executed Batch Record for the Batch, CLIENT shall determine whether Drug Product conforms to the Drug Product Specifications, the Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).

  • XXXXXX shall notify CLIENT of and require written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.

  • Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to ALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).

  • Changes or modifications required to address the requirements of Regulatory Authorities shall be (i) borne and paid for by Replidyne if related to Drug Substance Specifications or Drug Product Specifications, or (ii) be borne and paid for by Nisso if related to the manufacturing or packaging processes.

  • If any Lot of Drug Product or amount of Finished Goods produced for Bioverativ by the Third Party Manufacturer is of a quantity that is lower than the expected yield range but otherwise meets the Drug Product Specifications or Finished Goods Specifications, Bioverativ shall accept such Lot or amount and Bioverativ’s sole remedy from Biogen shall be limited to the same remedy to which Biogen is entitled from its Third Party Manufacturer for such Lot or amount size shortfall.

  • Biogen has the right to disqualify any quantity of Drug Product or Finished Goods for failure to comply with the Drug Product Specifications or Finished Goods Specifications, cGMPs or with other requirements (as determined in Biogen’s sole discretion) and to decide not to release such Drug Product or Finished Goods.

  • SPA shall pay to RTU an Annual Maintenance service fee based on Drug Product Specifications and Commercial Product Orders as follows: [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 ofThe Securities Exchange Act of 1934, as amended.

  • Control of Drug Product Specifications [*] Stability Testing of Crofelemer Tablets [*] Nonclinical Plans [*] * Confidential treatment requested; certain information omitted and filed separately with the SEC.


More Definitions of Drug Product Specifications

Drug Product Specifications means the testing SPECIFICATIONS for DRUG PRODUCT as set forth in Exhibit 5, as may be revised from time to time by the PARTIES in accordance with Change Control.
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Drug Product Specifications. For each Distribution Product, the following information: (i) the active ingredient or ingredients contained therein, (ii) the type of formulation and, if applicable, any devices for the administration thereof, (iii) packaging design and configuration specifications, (iv) package material specifications and artwork required for packaging, and (v) the specifications that the Distribution Product must meet upon completion of the Formulation and the Packaging Manufacturing Stages that would be included in a certificate of analysis.
Sample 1
Drug Product Specifications means the written release specifications for the Drug Product as set out in Exhibit B, which shall be superseded and replaced by specifications to be incorporated in the Quality Agreement, and which may be amended from time to time by the Parties in accordance with Section 5.4 and the Quality Agreement.
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Drug Product Specifications mean the specifications for the DRUG PRODUCT as set forth in Exhibit 7, or as otherwise agreed by the Parties in writing.
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Drug Product Specifications means the written specifications for the Manufacture of a Drug Product hereunder, as detailed in the applicable Drug Product Appendix.
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Related to Drug Product Specifications

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

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

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

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

  • 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.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • 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 Process means any process for—

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

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

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

  • API means the American Petroleum Institute.

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

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

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

  • 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;

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • 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.

  • 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.

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

  • Project Specific IPRs means: (a) IPRs in the Services provided by the Supplier (or by a third party on behalf of the Supplier) specifically for the purposes of the Contract and all updates and amendments of these items created during the Contract Period; and/or (b) IPRs arising as a result of the provision of the Services by the Supplier (or by a third party on behalf of the Supplier) under the Contract, [including the rights in or to any database developed and supplied by the Supplier to the Customer in accordance with the terms of this Contract;