Filled Drug Product definition

Filled Drug Product means Bulk Substance that has undergone the additional manufacturing steps of formulation and filling, but not labelling and packaging other than as required for delivery of unlabeled vials (i.e. not labeled and packaged for use in a clinical trial).”
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Filled Drug Product means Product filled in vials, before their labeling and packing for sale to the market in the Territory.
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Filled Drug Product means Bulk Substance that has undergone additional manufacturing by or on behalf of KaloBios including but not limited to formulation and filling but not labeling.
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Examples of Filled Drug Product in a sentence

  • Quality inspection of Filled Drug Product (FDP) shall occur when Novavax performs release testing, in order to confirm that the product complies with Novavax’s release specifications and criteria.

  • Following execution of this Quality Agreement, changes to the facilities in which Filled Drug Product is Manufactured (as listed in Appendix 1), shall follow the Change Control requirements in this Quality Agreement.

  • Reprocessing of Filled Drug Product will only be permitted based on the criteria defined in Section 4.7 of the Sanofi Internal Quality Agreement.

  • Per Section 8 of the Sanofi Internal Quality Agreement, Sanofi or its subcontractor shall evaluate all proposed changes that may have the potential impact to Filled Drug Product or process specific attributes in accordance with cGMP requirements, using their respective approved change management systems.

  • Section 7 of the Plant Variety Protection Act of 1970 (the Act) (7 U.S.C. 2327) requires the renewal of a Plant Variety Protection Board (the Board).

  • The stability program shall be in compliance with cGMP and ICH requirements and all provisions defined per Section 6.6 of Part 1 above for the Drug Substance apply equally to the Filled Drug Product.

  • Sanofi shall notify KaloBios, within a reasonable period of time, of any upcoming Regulatory Inspections to be conducted at the Facilities relating to the Filled Drug Product or related process.

  • KaloBios’ Quality unit shall inform Sanofi’s Quality unit of any deviations/non-conformances related to the cold chain maintenance or other major problem with the Filled Drug Product identified upon receipt of Filled Drug Product by KaloBios.

  • Appendix 4, the Sanofi Internal Quality Agreement, and Appendix 5, the [***] Technical Conditions Document, define the requirements and responsibilities for defining the Manufacturing process for Filled Drug Product, including finalization of Master Batch Records, the in-process and sampling/testing control program, and provisions for process validation plans, analytical validation and stability studies.

  • KINIKSA may take Delivery of Filled Drug Product and Formulated Bulk Product on different Delivery Dates, even if KINIKSA ordered Filled Drug Product and Formulated Bulk Product in the same Purchase Order.

Related to Filled Drug Product

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

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

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

  • Covered drug means any prescription drug that:

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

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

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Licensed Compound means [***].

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Vapor product means any:

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.