Client situation & approach
Our client is an Active Pharmaceutical Ingredient (API) company located in Ireland. The objective of this program was to reduce the overall lead time from the manufacture of the product to the final release (Quality Control and Quality Assurance). We supported in:
- 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).
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 mindset growing within the laboratories.
