Common use of Batch Records Clause in Contracts

Batch Records. CIRCA will supply for each batch of Product, including ------------- each pilot batch, complete batch production and control records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product will be prepared by CIRCA at the time such operations occur. The records will include, without limitation, mixing and filling records; container and component traceability records; equipment usage records; in-process and final laboratory testing results; in-process and final Product physical inspection results; yield reconciliation for bulk and finished Product; labeling and packaging records; and records relating to deviations from approved procedure, as well as CIRCA's investigation and corrective actions. Copies of batch records will be forwarded to CEPHALON prior to or along with shipment of each Product lot.