Drug Product Batch definition

Drug Product Batch means a specific quantity of the Drug Product that is intended to be of uniform character and quality and is produced during the same aseptic filling campaign.
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Drug Product Batch means a drug product Batch of Product in its final dosage form which uses material from a Drug Substance Batch as a starting material.
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Examples of Drug Product Batch in a sentence

  • Authorities 23 CFR 230.409 FHWA Form-1273 Types of Comprehensive Compliance Reviews NDOT performs two types of Comprehensive Compliance Reviews: project-based and contractor-based.

  • BI Pharma may conduct a Review by: (i) reviewing the Certificate of Analysis and the Manufacturing Documentation and such other documents, if any, as BI Pharma may request; and (ii) conducting acceptance testing of a representative sample of the Drug Product Batch.

  • For each Drug Product Batch to be delivered to BI Pharma or to a recipient designated by BI Pharma, ImmunoGen shall prepare and submit a representative sample of such Drug Product Batch, and a Certificate of Analysis that identifies the items tested, the applicable specifications and test results.

  • Moreover, the foregoing applies only if nonconformance is detected prior to the expiry date of the Drug Product Batch.

  • The authorities conferred on the Office and the Director by this chapter shall be ex- ercised in a manner consistent with provi- sions of the National Security Act of 1947 (50U.S.C. 401 et seq.).

  • In the event that any Drug Product Batch after delivery to BI Pharma is detected to fail to comply with the Final Specifications, ImmunoGen shall, at its own cost (a) deliver replacement quantities of such Drug Product to BI Pharma or make up the shortage, as the case may be, [ * ]; or (b) if replacement is not possible despite ImmunoGen's [ * ], at BI Pharma's discretion, either refund or credit BI Pharma's account for the amount paid for such Drug Product.

  • Prior to delivery to BI Pharma, ImmunoGen shall test, or cause to be tested, a representative sample of each Drug Product Batch (or components as applicable) to demonstrate that such Drug Product Batch complies with the applicable specifications (manufacturer's release).

  • Lonza shall not be responsible for the cost of Raw Materials, Customer Materials and/or starting materials consumed in any Failed Drug Substance Batch or Failed Drug Product Batch except to the extent set forth in Clause 7.5.3.

  • In the event that any Drug Product Batch after [ * ] to BI Pharma is [ * ] to [ * ] to [ * ] with the [ * ], ImmunoGen shall, [ * ] (a) [ * ] of such Drug Product to BI Pharma or [ * ] the [ * ], as the case may be, [ * ]; or (b) if [ * ] is not possible [ * ], at [ * ], either [ * ] or [ * ] for the [ * ] for such Drug Product.

  • Prior to delivery to BI Pharma, ImmunoGen shall test, or cause to be tested, a representative sample of each Drug Product Batch (or components as applicable) to demonstrate that such Drug Product Batch complies with the applicable specifications (manufacturer’s release).

Related to Drug Product Batch

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

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

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

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

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

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

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

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • 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.

  • 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;

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • API means the American Petroleum Institute.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Licensed Compound means [***].

  • 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.

  • 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.