Batch Documentation

Batch Documentation. Means all documentation relating to a Batch, including the executed Batch record (EBRs) and additional documents relating to the Batch such as the analytical testing records, the release for the Materials, deviations, and all documents relating directly to a Batch that Corden is required to maintain according to cGMP, the Specifications, service requirements , the Quality Agreement, the relevant Purchase Order or Work Order, and all Applicable Laws. These records are generated by Corden's... Quality Control and reviewed and approved by Quality Assurance. View More

Batch Documentation. The documents and other records that are produced in connection with the Manufacture of a particular Batch and/or lot.