Drug Product Specification definition

Drug Product Specification means the specification for Drug Product as defined in the Quality Agreement.
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Examples of Drug Product Specification in a sentence

  • Drug Product Specification You should provide a drug product specification that accounts for specific attributes for your liposome products.

  • N/A · Perform Product and Drug Product testing against Product and Drug Product Specification.

  • Drug Product Specification - Sterility The drug product specification should include a sterility specification and test method.

  • SPECIFICATION AND BATCH DATA 313.1. Drug Substance Specification 313.2. Drug Product Specification 323.3. Batch Data 334.

  • RECOMMENDATION(b)(4)(4)From the Biopharmaceutics perspective, since the Applicant made a commitment on 02/20/14 to tightening the dissolution acceptance criterion from Q= (b) % at 30 min to % at 30 min and to updating the Drug Product Specification section by 02/26/14, this NDA is recommended for approval.

  • Rise of authoritarian states in Japan, Italy, and Germany in the 1920s and 30s.

  • Since the proposed assay and impurity HPLC method for the drug substance and drug product is different from the USP regulatory methods in the respective monographs, add a footnote in your Drug Substance and Drug Product Specification tables indicating that the HPLC test method is an alternative method.

  • In cases where product manufacture is based upon potency, there may be no need for an alternate determination of quantity.4.2 Drug Product Specification Generally, the following tests and acceptance criteria are considered applicable to all drug products.

  • Enamel loss at bond-up, debonding and clean-up following the use of a convencional light-cured composite and a resin-modified glass polyalkenoate cement.

Related to Drug Product Specification

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

  • 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.

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

  • 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.

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

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

  • 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.

  • Manufacturing Process means any process for—

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

  • 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.

  • 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.

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

  • API means the American Petroleum Institute.

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

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

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

  • 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.

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

  • 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.

  • 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.

  • Goods Specification any specification for the Goods including any relevant plans or drawings, that is agreed in writing by the Reseller and Voip-Unlimited.

  • 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;

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • 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;

  • 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;

  • 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.