Master Batch Records (MBRs), which are general manufacturing instructions, are a critical piece of manufacturing execution systems (MES). They provide the basis for the description of pharmaceutical manufacturing processes, which later leads to Batch Records containing all pharmaceutically relevant data: the input material list, valid SOPs, detailed work instructions to be applied in production, and also process data – or process steps – such as in-process controls (IPCs), Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
