API Starting Material definition

API Starting Material means a raw or intermediate material that is used in the manufacturing of an API, that is incorporated as a significant structural fragment into the structure of the API, and that is determined by the FDA Commissioner to be relevant in assessing the safety and effectiveness of Essential Medicines and Medical Countermeasures.
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API Starting Material means DCA-129 [***] as set forth in exhibit A-1.
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API Starting Material means the raw venom of the Malayan pit viper, as described in Appendix 2.
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Examples of API Starting Material in a sentence

  • An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.

  • Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps.

  • Where the API Starting Material is a commercial molecule the requirement to provide these details (if needed for confidentiality reasons: directly to the authorities only) may be included in the commercial contract.

  • Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.

  • Request by the QP(s) or Responsible Person(s) of the Manufacturing Authorisation Holder(s): Third Party Audit of API Starting Material used in Medicinal ProductsRequest by the API Manufacturer / Distributor / Broker/ Importer/ Packer / Re-Packer: Self Assessment Audit of GMP status ACI = API Compliance InstituteAuditee = API Manufacturer / Distributor / Broker/ Importer/ Packer / Re-PackerQP = Qualified PersonManuf.Auth.Holder = Manufacturing Authorisation Holder for Human or Veterinary Medicinal Products.

  • Where the proposed API Starting Material is close to the API itself ensure that details on the synthetic process and analytical controls used to manufac- ture the API Starting Material are available in case these would still be (justi- fiably) requested by the regulators.

  • API Starting Material (Produit de départ de l’IPA) – A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

  • An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in- house.

  • Table 1 in ICH Q7 shows the increase in GMP from the introduction of the API Starting Material to the final API.

  • Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process.From this point on, appropriate Good Manufacturing Practices as defined in this Guide should be applied to these intermediate and/or API manufacturing steps.


More Definitions of API Starting Material

API Starting Material means a raw material that is used in the production of an API and that is incorporated as a significant structural fragment in to the structure of the API. API starting material are normally commercially available and of defined chemical and physical properties and structure.
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Related to API Starting Material

  • Marketing Material means bank books, bank information memoranda, offering memoranda, offering circulars, road show presentations, prospectuses, registration statements and other information packages, similar materials and marketing materials (including, to the extent necessary, an additional bank information memorandum that does not include material non-public information), in each case, prepared in connection with the Financing and reasonably requested by Parent or the Financing Sources that is customarily delivered in connection with debt financings of the type being arranged.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Reporting Material means all Material which the Grantee is required to provide to the Commonwealth for reporting purposes as specified in the Grant Details and includes any Existing Material that is incorporated in or supplied with the Reporting Material.

  • 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.

  • Packaging Materials means art and mechanical formats for a Software Title including the retail packaging, end user instruction manual with end user license agreement and warranties, end user warnings, FPU media label, and any promotional inserts and other materials that are to be included in the retail packaging.

  • Training Materials means any and all materials, documentation, notebooks, forms, diagrams, manuals and other written materials and tangible objects, describing how to maintain the Facilities, including any corrections, improvements and enhancements thereto to the Bloom Systems which are delivered by Operator to Owner, but excluding any data and reports delivered to Owner.

  • propagating material has the meaning given to it in the PBR Act, namely in relation to a Plant of a particular Plant Variety, means any part or product from which, whether alone or in combination with other parts or products of that Plant, another Plant with the same essential characteristics can be produced.

  • Existing Material means Material developed independently of this Agreement that is incorporated in or supplied as part of Reporting Material or Activity Material.

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

  • Instructional material means instructional content that is provided to a student, regardless of its format, including printed or representational materials, audio-visual materials, and materials in electronic or digital formats (such as materials accessible through the Internet). The term does not include academic tests or academic assessments.

  • Remarketing Materials means the Preliminary Prospectus, the Prospectus or any other information furnished by the Company to the Remarketing Agent for distribution to investors in connection with the Remarketing.

  • 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;

  • maximum content of non-originating materials means the maximum content of non-originating materials which is permitted in order to consider a manufacture to be working or processing sufficient to confer originating status on the product. It may be expressed as a percentage of the ex-works price of the product or as a percentage of the net weight of these materials used falling under a specified group of chapters, chapter, heading or subheading;

  • Promotional Material means all material used in the promotion of, or otherwise in connection with, the Business (whether written or recorded in any other medium) and includes artwork, advertising materials (irrespective of the medium in which they are recorded), display materials, packaging materials, brochures, posters and internal and external signage.

  • Input Material means all documents, information, representations, statements and materials provided by Customer or a third party on behalf of Customer, relating to the Services, including computer programs, data, logos, reports and specifications and inventories.

  • Meeting Materials means the notice of meeting, the Circular and the form of proxy in respect of the Meeting which accompanies the Circular.

  • Offering Materials means a Fund’s currently effective prospectus and most recently filed registration statement with the SEC relating to shares of the Fund.

  • Goods Specification means any specification for the Goods, including any related plans and drawings that is set out in the Purchase Order or otherwise agreed in writing by the Customer and the Supplier;

  • Supplemental Marketing Material means any Issuer Free Writing Communication other than any Issuer Free Writing Communication specified in Schedule B hereto. Supplemental Marketing Materials include, but are not limited to, any Issuer Free Writing Communication listed on Schedule C hereto.

  • 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;

  • Instructional materials means relevant instructional

  • Original Material means a material provided by one of the Parties and used in the Research Project.

  • Promotional Materials means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.

  • API means the American Petroleum Institute.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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. The Contract Specifications appear on the Website.