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Reduce batch record review for a Solid Dose (Small Molecule) Pharmaceutical company

Client situation & approach

Our client is a Solid Dose (Small Molecule) Pharmaceutical company in a Global multi-site environment in in North America. The primary objective of this project was to reduce batch record review and disposition times to facilitate accelerated release of product to market. Ancillary objectives included increasing QA team productivity through implementation of capacity planning and standard work and streamlining of deviation management processes. We supported in:

  • At a Regional level: A standardized approach for managing batch review and disposition workloads including capacity planning and monitoring of key performance indicators
  • At a Site level: Levelling, flow and standard work solutions tailored to the site-specific targets. Implementation of effective visual management systems that optimized daily internal processes and customer delivery. Design and implementation of a digital visual management solution for site-wide deviation management

Results

  • Reduction of batch record cycle time from an average of 12 days to 48 hours or less
  • Self-directed work teams capable of overcoming transient workload peaks through capacity resource modelling, ultimately ensuring robust supply chain delivery
  • Increased visibility and oversight of deviations with concomitant rapid escalation and resolution through the implementation of a digital visual management system