Fill Finish definition

Fill Finish means the compounding, filling, producing and primary packaging in accordance with the Manufacturing Specifications and the terms and conditions set forth in the Agreement and any applicable SOW.
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Fill Finish means the compounding, filling, producing and primary packaging of Drug Product in accordance with the applicable Specifications.
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Fill Finish means (a) formulating the Licensed Product using Drug Substance and other excipients, (b) filling the Licensed Product into vials, (c) lyophilization of the Drug Substance for incorporation into the Licensed Product, and (d) testing, including ongoing stability testing, and release of the Licensed Product. For the avoidance of doubt, Fill/Finish shall not include any activities included in the definition of Labeling and Packaging.
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Examples of Fill Finish in a sentence

  • The effluent limitations for BOD5 and BOD percent removal have been carried over to the proposed Order.

  • Drug product labeling and packagingwill be done at Genentech Hillsboro Fill Finish Facility in Hillsboro, Oregon.(b) (4)You may label your product with the proprietary name, Kadcyla, and will market it as a lyophilized product in two single-use presentations of 100 mg per vial and 160 mg per(b) (4)vial.Trastuzumab intermediate will be manufactured at Genentech, Inc., Vacaville, CA and Roche Singapore Technical Operations Pte.

  • Site Boundary Map In February 2014, Alexion Pharma International Trading (APIT) acquired the existing Sterile Fill Finish facility - part of the former Alkermes site (P0100-02).

  • CMO Perspective and Experience of Recent Inspections Youwen Pan, WuXi Biologics ▪ Experience of recent interactions with inspectors from FDA and China NMPA on Vanrx SA25 Panel Discussions and Q&A with Speakers and ExpertsSpeakersRuth Barensteiner Janssen PharmaceuticalsRuth Barensteiner is working at Janssen Pharmaceu- tical Discovery, Product Development and Supply as Compliance Manager in the Fill Finish Pilot Plant for the manu- facturing and supply of clinical trial material.

  • Accelerated tender opportunities will be provided to level 4 and level 3 and higher B-BBEE contributors.

  • Prior to the Manufacture or Fill Finish by Biogen of any Drug Substance or Drug Product required to be Manufactured or Fill Finished in accordance with cGMP, including materials to be used in human clinical trials, the Parties shall negotiate in good faith and enter into a quality agreement starting from Biogen’s standard template or as otherwise agreed by the Parties (“Quality Agreement”).

  • To the extent Biogen has accepted a Manufacturing Request in accordance with Section 2.1.2, subsequent to which the Services include pre-commercial/clinical Manufacturing and/or Fill Finish, the following shall apply except to the extent that the Parties otherwise agree in writing.

  • SW-1 emission point includes runoff from the Fill Finish and Warehouse Building and the car park to the west of this building.

  • Fill Finish Within this area Drug Product is filled into either 2ml or 20ml vials.

  • Starting in 2012, BARDA has awarded over $40 million in contracts to four contract development and manufacturing organizations (CDMOs) to establish the Fill Finish Manufacturing Network (FFMN).


More Definitions of Fill Finish

Fill Finish means [***].
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Fill Finish means the fill and finish, bulk packaging, testing and release of Drug Product to be performed by Supplier hereunder, including (a) filling the Drug Substance into vials and (b) testing, including in process release to Labeling and Packaging and ongoing stability testing of the Drug Product. For the avoidance of doubt, Fill/Finish shall not include any activities included in the definition of Labeling
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Fill Finish means (a) formulating the Product using Drug Substance and required excipients, (b) filling the Product into vials, (c) lyophilization of the Drug Substance for incorporation into the Product, and (d) testing, including ongoing stability testing, and release
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Fill Finish means (a) formulating the PRODUCT using DRUG SUBSTANCE and required excipients, (b) filling the PRODUCT into vials, (c) lyophilization of the DRUG SUBSTANCE for incorporation into the PRODUCT, and (d) testing, including ongoing stability testing, and release of the PRODUCT. For the avoidance of doubt, FILL/FINISH shall not include any activities included in the definition of LABELING AND PACKAGING.
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Fill Finish means the formulating of the Compound, and filling, finishing and storage of such formulated Compound in unlabeled vials, so that such vials are ready to be shipped to the quality control/qualified person and the Secondary Packaging site.
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Fill Finish means (a) formulating the PRODUCT using DRUG SUBSTANCE and required excipients, (b) filling the PRODUCT into vials, (c) lyophilization of the DRUG SUBSTANCE for incorporation into the PRODUCT, and (d) testing, including ongoing stability testing, and release of the PRODUCT. For the avoidance of doubt, FILL/FINISH shall not include any activities included in the definition of LABELING AND PACKAGING. “FINAL PRODUCT” shall mean PRODUCT produced entirely by FIOCRUZ at the FACILITIES from the CELL BANK.
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Related to Fill Finish

  • Faux finishing coating means a coating labeled and formulated as a stain or a glaze to create artistic effects including, but not limited to, dirt, old age, smoke damage, and simulated marble and wood grain.

  • Fabrication means making up data or results and recording or reporting them.

  • Tight-fitting facepiece means a respiratory inlet covering that forms a complete seal with the face.

  • Stack means any point in a source designed to emit solids, liquids, or gases into the air, including a pipe or duct but not including flares.

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

  • Connector means a flanged, screwed, welded, or other joined fitting used to connect two pipelines or a pipeline and a piece of process equipment.

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

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

  • Submerged fill pipe means any fill pipe the discharge opening of which is entirely submerged when the liquid level is six inches [15.24 centimeters] above the bottom of the tank; or when applied to a tank which is loaded from the side, means any fill pipe the discharge opening of which is entirely submerged when the liquid level is one and one-half times the fill pipe diameter in inches [centimeters] above the bottom of the tank.

  • Assembly means the Assembly of Heads of State and Government of the African Union;

  • Fill means the addition of soil, sand, rock, gravel, sediment, earth retaining structure, or other material to an area waterward of the OHWM, in wetlands, or on shorelands in a manner that raises the elevation or creates dry land.

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

  • Front fog lamp means the lamp used to improve the illumination of the road in case of fog, snowfall, rainstorms or dust clouds;

  • Design-build team means an entity that consists of:

  • SCD means current City of Winnipeg Parks Planning Standard Construction Detail Drawings.

  • 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.

  • Boot camp means a short term secure or nonsecure juvenile residential facility with highly

  • Uppermost aquifer means the geologic formation nearest the natural ground surface that is an aquifer, as well as lower aquifers that are hydraulically interconnected with this aquifer within the facility's property boundary.

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

  • Brand Name or Equal Specification means a specification which uses one or more manufacturer’s names or catalogue numbers to describe the standard of quality, performance, and other characteristics needed to meet District requirements, and which provides for the submission of equivalent products.

  • Double check valve assembly means an assembly composed of two single, independently acting, check valves including tightly closing shutoff valves located at each end of the assembly and suitable connections for testing the water tightness of each check valve.

  • HDPE means high density polyethylene;

  • Patch means minor modifications to the Licensed Product made by Registry Operator during the performance of error correction services. A Patch does not constitute a Version.

  • Bulkhead means an airtight structure separating the working chamber from free air or from another chamber under a lower pressure than the working pressure;

  • Open type traction battery means a type of battery requiring liquid and generating hydrogen gas released to the atmosphere.

  • 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.