Batch definition
Examples of Batch in a sentence
Concurrently with each shipment of the Products, Hanmi shall deliver to Spectrum the Released Executed Bach Records with all attachments including, without limitation, the Certificate of Analysis and Certificate of Compliance for each Batch of the Product included in the shipment confirming that the Product has been Produced in accordance with this Agreement.
If during the Production of any Batch of a Product, any reprocessing or reproduction is permitted and required in order to meet the Product Specifications, Hanmi will conduct such reprocessing in compliance with cGMP and the BLA.
Hanmi will test, or cause to be tested by third party testing facilities agreed upon in writing by Spectrum and Hanmi and audited by Hanmi, in accordance with Testing Standards and Procedures, each Batch of a Product Produced pursuant to this Agreement before delivery to Spectrum.
If Spectrum establishes that any shipment of a Product does not conform to the Product Requirements (“Nonconforming Product”), then Spectrum will give Hanmi written notice thereof as soon as practicable but in no event later than [***] from the date of delivery of both the Product and the Released Executed Batch Record and will, unless otherwise directed by ▇▇▇▇▇, return only the Nonconforming Product for further testing by ▇▇▇▇▇.
Within [***] from the date of delivery of both the Product and the Released Executed Batch Record to Spectrum, Spectrum will determine, based on agreed release testing procedures, whether such Product conforms to Product Specifications and the Master Batch Record (collectively the “Product Requirements”).