Common use of Batch Records Clause in Contracts

Batch Records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product shall be prepared by Supplier for each lot at the time at which such operations occur. The records shall include, but are not limited to, the following documentation: manufacturing, raw materials and components charge-in-records; mixing and filling records; packaging component charge-in records; packaging records; container and component traceability records; in-process and final laboratory testing results; in-process and final product physical inspection results; yield reconciliation for bulk and finished product; label samples; deviations and/or excursions from approved procedure (as well as the Supplier investigation and corrective actions) incurred during the processing and packaging of the lot. Company may review the original documents for each lot at its request when auditing the manufacturing site of Product(s). Supplier shall keep all batch records according to this section [*] after the expiration date of each Product lot.