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

  • 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.

  • If the Parties do not agree, then VERSARTIS can request BI to produce a new Drug Product Batch [*] used in the manufacture of such Drug Product Batch.

  • 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 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.

  • 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 [ * ].

  • 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).

  • If Customer provides a Cancellation Notice of a Drug Product Batch to Lonza less than or equal to […***…] prior to the Commencement Date of such Drug Product Batch, then a Cancellation Fee of […***…] percent […***…] of the Batch Price of each such Drug Product Batch cancelled is payable.

  • 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).