At GPCM (Global Pharmaceutical Contract Manufacturing) Event in London, UK, Director of External Manufacturing for Eli Lilly, Miriam McCloskey, spoke to delegates about the importance of applying metrics data in order to manage relationships with third-party manufacturers.
“We are accountable for the performance of our partners, and our partners are looked at across Eli Lilly in the same way as we look at our internal sites,” she said. “The core metrics are the same, giving senior management the opportunity to look at comparisons across internal and external sites.”
She continued, adding: “If you don’t look at these then ultimately there will be some issues and things will get missed, so the right metrics will increase this probability of success and give you advance warnings if things are going to go out of control.”
In her address, McCloskey also spoke of the importance of agreeing metrics with the CMO (contract manufacturing organization) as part of a good collaboration management and though she welcomed partners to offer their own metrics, Lilly’s minimum operational expectations were set out. This included:
- Conformance to the quality plan
- Quality Backlog
- Yield variance
- OTIF (On Time In Full) rate
- Percentage of batch rejections and recalls
The use of a ‘red-amber-green scorecard’ offers – according to McCloskey - a simple and effective way of monitoring these operational requirements. “There is a lot of pride in the relationship in having a fully green scorecard,” she said, which demonstrates the “joint performance of the group together.”
Big Pharma & CMO Streamlining
Lilly’s collaborative approach was deemed softer than that of Roche, who – also at GPCM – spoke of its high governance strategy towards its sterile manufacturing partners.
Delegates at the meeting questioned whether Roche was stepping on the toes of its partners by having higher expectations than the CMO itself, imposing its own presence on the site, creating a task-force and regularly accessing the CMO’s KPIs.
However, both Lilly and Roche said their performance monitoring of their CMOs played a part in streamlining their external partners.
“In Europe, Africa and Asia We have about 20 partners,” said McCloskey. “It used to be a lot higher but, similarly to a lot of other big pharma, we have been going through that process of reducing the overall number across all the different hubs over the last ten years.”