batchrecords

Batch records are formal documents used in manufacturing to capture the complete history of a production batch from raw materials through finished product. They provide a traceable, verifiable record of how a batch was produced, tested, and released, and they support quality control, regulatory compliance, and product recalls when necessary.

A batch record typically includes identifiers for the product and batch, materialIssuance and material receipt details, equipment and facility information, and a step-by-step description of the manufacturing process. It records critical process parameters, such as time, temperature, pressure, and environmental conditions, as well as in-process checks, sampling results, and testing outcomes. The record also documents any deviations, investigations, change controls, rework, hold points, cleaning activities, packaging, labeling, and final disposition decisions. Signatures or electronic approvals from authorized personnel confirm responsibility at each stage.

In regulated industries such as pharmaceuticals, biotechnology, food and beverage, and cosmetics, batch records are essential for quality assurance and regulatory compliance. They may be maintained as paper documents or electronic batch records (eBRs), with strict data integrity, access control, and audit trail requirements. retained for specified periods and subject to QA review and approval before batch release.

Overall, batch records enable traceability, accountability, and evidence-based decision making, supporting product safety, quality, and regulatory readiness.