Validation Batch definition

Validation Batch has the meaning provided in Section 4.2 of this Agreement.
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Validation Batch means a batch or lot produced from a validation run. Each Validation Batch is intended to produce Product that is commercially saleable when contained in a finished Paratek Product.
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Validation Batch means a batch of Product, data from which is used to demonstrate the efficacy of the manufacturing process, the reproducibility of Product quality, Product stability, and other parameters which may be required by regulatory authorities in order to grant approval of the manufacturing process and Product quality.
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Examples of Validation Batch in a sentence

  • ACP will complete Validation Batch #1, Validation Batch #2 and Validation Batch #3 for one indication as described in Exhibit A to the Master Service Agreement entered into by parties as of January 28, 2015 as of the Effective Date.

  • Activity 8: Validation Reports 20 working days after completion of Validation Batch #3, or 20 days from date requested by RADIUS Activity 9: Validation Stability Stability study to start within one month of batch purification and continue according to protocol Activity 10: DMF Filing Within 40 working days of date requested by RADIUS, but not earlier than 3.5 months after the end of the Validation Campaign.

  • Genchem Pharma shall cause Sicor to include with each shipment of a Validation Batch to Anthra a certificate of analysis thereof.

  • For the avoidance of doubt, in the event the manufacturing slot for a Validation Batch is replaced with a Batch of Commercial Product due to events that are under Curia's control, or pursuant to Section 4.4 above, Indivior shall not pay a rescheduling/cancellation fee for such rescheduled/cancelled Validation Batch.

  • In the event of a Validation Batch failure due to Curia's gross negligence or willful misconduct, Indivior shall have, in its sole discretion, the right to either (i) have Curia re-make the relevant Validation Batch at no further cost to Indivior (provided Indivior pays for the conforming replacement services solely in the event Indivior has not already paid for the non-conforming services) or (ii) to have Curia credit to Indivior the amount paid by Indivior for such failed Validation Batch.


More Definitions of Validation Batch

Validation Batch means a batch of saleable product manufactured prior to NDA approval to confirm that the process set forth in the NDA is reproducible at commercial scale, and which meets FDA requirements for a validation process.
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Validation Batch means a full GMP batch of a specific batch size that shall prove that the Process in use delivers batches of releasable quality in full accordance with specifications.
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Validation Batch means a Batch that requires testing and documentation beyond what is required per this Agreement.
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Validation Batch means any one of each of three (3) consecutive batches of API or dosage form which conform to the critical parameters described in the process and which are Manufactured according to the Manufacturing process.
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Validation Batch means any one of three (3) consecutive batches of API Compound which confirm the critical parameters described in the synthetic process which are manufactured by Supplier according to cGMP, are validated in accordance with the Act and meets the Specifications.
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Validation Batch means a batch of PRODUCT (a) that (i) conforms to the parameters described in the validation protocol as agreed in writing between the parties, (ii) is manufactured according to cGMP, as applicable, (iii) is validated in accordance with the ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (the “ICH Guidance”) (including, without limitation, that such batch, together with two other such sequential batches of PRODUCT, demonstrates reproducibility of the commercial manufacturing process for PRODUCT), (iv) supports the NDA (or other filing for Regulatory Approval) for PRODUCT, (v) may be used to complete the consistency, comparability and stability studies for PRODUCT in connection with any such filing, and (vi) meets Specifications; or (b) supports a filing for Regulatory Approval of the implementation of a subsequent process or equipment change with respect to the commercial manufacture of PRODUCT. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Validation Batch means a batch of approximately 580 kg of API, but in no event less than 450 kg of API, produced pursuant to Section 3.8 and the Validation Protocol.
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