Batch Record

A batch record (also called a batch production record or batch manufacturing record) is a detailed document that captures every step, material, measurement, and observation associated with the manufacture of a specific batch of product. It includes raw material lot numbers and certificates of analysis, equipment identification and calibration status, environmental monitoring data, in-process test results, operator identifications, timestamps, deviations and corrective actions, and final release testing outcomes. Batch records provide complete traceability from raw materials to finished product and are a core requirement of Good Manufacturing Practice (GMP) regulations enforced by agencies such as the FDA and EMA. For peptide products, the batch record documents the synthesis, purification, formulation, sterile fill, and packaging of each production lot. ORYN maintains complete batch records for every production run, enabling full traceability of each peptide pen from amino acid starting materials through to the finished product that reaches the customer, and supporting the certificates of analysis provided with each batch.