How to do speedy manufacturing site change for bio-pharma products? A Kanban and Kaizen Case Study

​Kanban and Kaizen Case Study

Problem: A multi-national bio-pharma company wanted to do a manufacturing site change for 55 products within an aggressive time frame of 5 months? Can this be done ? How ?

Due Diligence:  A due diligence of proposed manufacturing site was done and gap analysis report was documented. The due diligence report, gap- block strategy recommendations as well as budget estimations were provided to the organization’s executive management team; to facilitate Go/Kill decisions.

Solution: Kanban and Kaizen methodologies were employed. Product wise site-transfer protocols were developed (especially taking into consideration the different product/ process complexities and challenges (both known and anticipated), production capability and market demands. A product wise ‘Risk Assessment and Mitigation’ protocol was developed.

Result Dashboard:

• All 55 products were transferred to new site as planned and within time & cost budget.

Note: The product development strategy is very important. Product made ‘glocal’ i.e. global appeal with local compliance and developed using QbD, exhibit very little issues while expanding to newer manufacturing sites.

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