1. Master Batch Record (MBR): This is a comprehensive document that provides detailed instructions for the manufacturing of a specific product. It includes information on raw materials, equipment, processing steps, and quality control tests. 2. Batch Manufacturing Record (BMR): This record is created ...

Traditionally, most pharmaceutical companies used paper records to maintain production batch records, commonly known as production batch master records. However, this method of documentation has numerous shortcomings. In 1997, the FDA accepted electronic batch records in pharmaceuticals after EBR systems ...