Drug Substance Specification definition

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

  • Sponsorship Opportunity Available)or Enjoy Lunch on Your Own 12:50 Session Break2:00 Monte Carlo Simulations of Amidite Starting Material ImpurityIncorporations for Drug Substance Specification JustificationsFrancis Ring, Assistant Director, Manufacturing and Operations, Ionis Pharmaceuticals For starting material-related product impurities, Ionis supplemented the product impurity data with Monte Carlo simulations of the corresponding starting material impurity.

  • Neither Party shall make any Product Specification changes and/or Drug Substance Specification changes as it pertains to the Product to be supplied in the Field in the Territory without prior written consent of the other Party, such consent not to be unreasonably withheld.

  • Each Batch shall be Produced and its Disposition carried out by using a copy of the Master Batch Record, the Process Specification and the Drug Substance Specification and the Quality Agreement Document.

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

  • Table 2: Micronized Product Specification [redacted] EXHIBIT C Specifications ST-246 Drug Substance Specification for Commercial Production PRODUCT SPECIFICATIONS [redacted] EXHIBIT D Stability Study [redacted] EXHIBIT E QUALITY AGREEMENT [redacted] EXHIBIT F Flow-down Provisions [redacted] EXHIBIT G BARDA Security Corrective Actions The Parties have participated in a pre-award security audit conducted by BARDA in 2009 that included the Facility (the “Security Audit”).

  • Specification: BDS-XYR-0400 Rev 13 Bulk Drug Substance Specification Effective Date: 02/16/05 Supersede Supersede Date: 09/10/03 Date: 09/10/03 Page:2 of 3 Sampling: Follow SOP-QA-0095 for sampling process.

  • Avecia Quality The function within Avecia responsible for review of documents produced during a Programme against the Drug Substance Specification and/or Drug Substance Requirements.

  • In such circumstances, test results should be considered as in-process acceptance criteria and included in the specification of drug substance or drug product in accordance with the requirements of the regional regulatory authorities.4.1 Drug Substance Specification Generally, the following tests and acceptance criteria are considered applicable to all drug substances (for analytical procedures see section 2.2.2).

  • 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.

  • Given that the St. Julian’s property has not generated any rental income in 2018, all development costs regarding this property were capitalised, thus justifying the increase in capitalised finance costs in 2018.

Related to Drug Substance Specification

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

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

  • 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.

  • 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 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.

  • 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.

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

  • 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:

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

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

  • 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.

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

  • 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.

  • 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.

  • Manufacturing Process means any process for—

  • 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.

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

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

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

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

  • API means the American Petroleum Institute.

  • Detailed Specifications means the specifications for materials and works as specified in PWD BSR/ issued under the authority of PWD/ or as implied/added to or superseded by the special conditions.

  • 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.

  • 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.