Real Lean Transformation

Active Pharmaceutical Ingredient (API).

Client Environment

Active Pharmaceutical Ingredient (API).


Geography

Ireland.

 

Objectives

Reduce the overall lead time from manufacture of the product to final release (Quality Control and Quality Assurance).

 

Solutions Deployed

Quality Control: queue based levelling and rhythm wheel, standard work roles, visual management.
Quality Assurance: batch record re-engineering, process optimization (batch record review and corrections, investigation management, disposition)

 

BSM Case Study - Active Pharmaceutical Ingredient (API)

 

Results

  • Reduction in QC lead time from an average of 13.4 days to an average of 4.7 days
  • Alignment of the QA timeline to the QC timeline i.e. disposition ready to complete as soon as the lab results are finalized
  • Fixed repeatable analyst requirement
  • Continuous improvement culture and mind-set growing within the laboratories