Master Batch Record (MBR) Generation, Review and Approval in a CDMO Environment


  • Our Client, a large contract development and manufacturing organisation (CDMO) engaged us to support an extensive end to end order fulfilment project with the objective of significantly improving OTIF delivery performance. Integral to this was the sub-process of MBR generation, review and approval / issuance. Multiple drivers of workload existed from both the customer side (artwork changes, item code changes, etc.) and internally from the client QMS (change requests, deviations etc.) As a result the process could be characterised as long, not transparent, variably executed and not in control. The objective was to reduce the leadtime, standardize the activities and design a solution to visually manage the process.

Solutions Deployed

  • A simple queue to level load with documents requiring updates launched into the process at a cadence to meet average incoming demand
  • MBR’s requiring updates flow through a defined and standardised sequence of drafting, review and approval activities
  • KPI defined for each phase of the process with particular emphasis on Lead time expectations
  • Twice weekly stand up meeting conducted within a strict frame of reference with all stakeholders (QA, Customer Services, Tech, Support, Doc Gen.) to review progress of MBR updates and execute remedial actions where necessary

leadtime in calendar-day increments


  • 200% improvement in the Lead Time to make MBR document updates effective
  • KPI trends used as a basis for launching focused improvement initiatives and as an input to developing problem solving capability in the stakeholder groups

Client Environment

Contract Development and Manufacturing Organisation