Master Batch Lot History Records

Batch production records document the completion of every step in the production process. Traditionally collected in paper format, electronic batch records (EBRs) are becoming the new standard. The manual assessment of the paper-based production records is a cumbersome process prone to errors that can result in product quality issues, recalls, warning letters, or even consent decrees. 

An electronic batch record (EBR) is a digital batch or production record that eliminates common pain points associated with paper-based batch records. EBR has the familiar look of paper and helps eliminate data entry errors that cause significant delays in time to market.

A batch release occurs after production record documentation has been reviewed and approved as meeting regulatory requirements. Only after batch or lot release can a manufactured product be shipped to the customer or the public.

A batch release occurs after production record documentation has been reviewed and approved as meeting regulatory requirements, allowing the product to be shipped to the customer or the public. In pharma, the quality control unit is charged with reviewing and approving all drug product production and control records, including those for packaging and labeling.