Examples of Conforming Batch in a sentence
If Synthorx does not notify Provider within the applicable time period that the Batch does not conform to the Work Order or cGMP (if applicable), then Synthorx will have accepted the Batch as a Conforming Batch and waived its right to revoke acceptance, and the drug substance or drug product must be deemed a conforming Synthorx Product.
Synthorx will notify Provider in writing of its acceptance or rejection of such Conforming Batch within […***…] of receipt of the complete Batch documentation relating to such Batch.
Each Batch will be sampled and tested by Provider in accordance to the approved Batch record, and Provider will review the documentation to assess if the Batch is a Conforming Batch.
If, based upon such tests and documentation review, Provider determines that a Batch is a Conforming Batch, then the Batch documentation for each Batch of drug substance or drug product will be delivered to Synthorx by an agreed upon courier.
In the event Synthorx discovers a Latent Defect in a Batch after Synthorx previously accepted such Batch as a Conforming Batch pursuant to paragraphs (d) or (e) of this Section, Synthorx will have one month from the date of acceptance of that Batch to reject such Batch because of the Latent Defect.
A Batch which; after review of the Disposition Package, is deemed by both Dyax’s and Fujifilm’s quality assurance groups to not meet the requirements of a Conforming Batch.
Each cGMP Batch will be determined to be a Conforming Batch or a Non-Conforming Batch in accordance with the Quality Agreement.
Each cGMP Batch will be determined to be a Conforming Batch or a Non-Conforming Batch.
Within the period specified in the Quality Agreement after Atara´s receipt of the Batch Documentation (the “ Product Acceptance Period”), Atara shall conduct the activities constituting the Atara Release to determine, by review of the Batch Documentation, whether or not Atara agrees that the given Batch is a Conforming Batch.