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.
Sample 1

Examples of Drug Product Batch in a sentence

  • ImmunoGen shall complete in accordance with the requirements of cGMP a Manufacturing Documentation and a Certificate of Analysis for every Drug Substance Batch and 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.

  • 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.

  • BI Pharma shall bear the cost and responsibility for the replacement of defective product attributable to instability until such time as the Parties determine stability over six months from data generated with the first cGMP Drug Product Batch.

  • BI Pharma shall conduct its Review within [ * ] of the receipt of a representative sample of the Drug Product Batch including Manufacturing Documentation of Drug Substance, [ * ] that [ * ] have a [ * ] of [ * ] for [ * ] after [ * ] of [ * ] and [ * ] after [ * ] of [ * ] the [ * ] .

  • Drug Product Batch size The batch size of the Bulk Drug Vials will be based on one full API Mixture batch of approximately [**].

  • 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).

  • 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).

  • BI Pharma shall conduct its Review within [ * ] of the receipt of a representative sample of the Drug Product Batch including Manufacturing Documentation of Drug Substance, [ * ] that [ * ] have a [ * ] of [ * ] for [ * ] after [ * ] of [ * ] and [ * ] after [ * ] of [ * ] the [ * ].

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.

  • 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.”

  • 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.

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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.

  • 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 American Petroleum Institute.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • 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.