ABSTRACT
The pharmaceutical industry is obliged to document carefully each step in the drug manufacturing process. Electronic batch recording systems (EBRSs) automatically create electronic batch records by collecting all the data that comes from the different manufacturing equipment, test results from in-process control (IPC), and other sources. To keep the batch record at reasonable length, only exceptions and deviations are reported, and the rest of the batch record is normally not reviewed. It can be considered that if a manufacturing process and associated materials are operating within specifications then there is no need to do a special review. The risk-based thinking behind this approach is to focus on the points that potentially could have an effect on the quality of the pharmaceutical product. This approach of review by exception (RBE) is acceptable if the manufacturing process, equipment, and systems are fully validated.
