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.

  • All investigations shall include evaluation of Filled Drug Product impact, root cause assessment and result in corrective or preventative actions, as required.

  • As defined in Section 5.1 of Sanofi Internal Quality Agreement, Sanofi or its subcontractor shall ensure that representative samples of each batch of Filled Drug Product are sampled and handled in accordance with cGMP guidelines for use as retained samples, analytical samples and stability testing samples.

  • KaloBios acknowledges that prior to the Effective Date of Amendment No 1 to the Supply Agreement, it consented to the subcontracting by Sanofi Pasteur to [***] the Manufacture of Filled Drug Product.

  • 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.

  • The overall responsibilities of each Party with regard to Bulk Substance and Filled Drug Product are defined in the provisions of this Quality Agreement, including, where applicable, where any such responsibilities have been subcontracted by a Party (i.e. Appendix 3: [***] QTA; Appendix 4: Sanofi Internal Quality Agreement; Appendix 5: [***] Technical Conditions Document).

  • Sanofi shall be responsible for supplying Filled Drug Product Manufactured by Sanofi or its subcontractor to KaloBios and for certifying that the Filled Drug Product has been Manufactured, tested and released to KaloBios for further processing, in accordance with [***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

  • CONFIDENTIAL TREATMENT REQUESTED Sanofi shall coordinate any required investigation at the site of Filled Drug Product Manufacture, as per Section 5.10.3 of Sanofi Internal Quality Agreement, and coordinate the collection of all required documentation, affidavits and expert advice associated with the investigation.

  • Sanofi or its subcontractor shall ensure that all documentation/records associated with the Manufacture of Filled Drug Product are retained for a minimum of 10 years after the Manufacture of the Filled Drug Product or as required by law.

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:

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • 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.

  • 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 product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • 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 or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • 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.