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).
Designing an MBR is to transform your current way of production into a new one: Your chance to improve the production and its connected processes by introducing an electronic batch recording system.
MBR design needs to be scheduled as early as possible and is usually planned directly after the fit verification phase (fit gap analysis), when the general concept has been defined and MES knowledge has been transferred. Important milestones include readiness for key user review, readiness for scale-up (duplication and PVL/PMBR creation), as well as the final design phase. Depending on the scope of the project, individual milestones can be set to track the progress of the MBR design and to link it to certain milestones related to other parts of the MES implementation project.
MBR design requires close cooperation between multiple departments. To achieve successful design, the right mix of people must work together – including staff from quality, system administration, MBR design, production (supervisors and operators) – along with key decision-makers. Werum consultants, with their profound process know-how and skills, support you to design high-quality MBRs.
Are you ready to improve your processes?