Validation Batch means a batch or lot produced from a validation run. Each Validation Batch is intended to produce Product that is or is expected to be (following Regulatory Approval) commercially saleable.
Validation Batch has the meaning provided in Section 4.2 of this Agreement.
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.
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.
More Definitions of Validation Batch
Validation Batch means a Batch that requires testing and documentation beyond what is required per this Agreement.
Validation Batch means a Batch that is produced with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies. ***Confidential Treatment Requested
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.
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.
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.
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.
Validation Batch has the meaning set forth in Schedule 2, Stage 8. “CommercialBatch” xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx “Commercial Campaign” xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx