We asked Steven Falcone , senior director , compliance and external engagement , pharma services , a few questions about how Thermo Fisher Scientific uses the quality concept to help improve supply chain resiliency
Quality & the pharmaceutical supply chain
We asked Steven Falcone , senior director , compliance and external engagement , pharma services , a few questions about how Thermo Fisher Scientific uses the quality concept to help improve supply chain resiliency
What are the key imperatives for CDMOs to bolster supply chain resiliency for themselves and their customers in these times of geopolitical shocks and disruption ? The first imperative is to simplify your supply chain by adopting a philosophy of using your CDMO ’ s material and equipment library for selection , where available . By adopting that philosophy in advance , you know you will be able to use back-ups and , in some cases , even a second tier of back-ups from that library . This will save money and time , and will speed up programme timelines and recovery from any interruption . It is also important to leverage the learnings of your CDMO .
What are the key ‘ quality ’ criteria a pharmaceutical company looks for in terms of product , process and value ? I have found that a pharmaceutical company first and foremost looks for a proven track record of the CDMO in bringing programmes forward successfully . It comes down to two critical factors : state-of-theart facilities and staff capability . Evidence of success means that the management system and the quality system are working hand-in-hand for programmes .
How does quality differ from regulatory compliance and meeting the customer ’ s key metrics ? Quality and regulatory compliance are related ; however , there is much more detail and nuance in customer programmes that require deep knowledge and experience . To put it another way , if regulatory compliance and customer metrics were all we needed for product manufacturing , then we would never need to do engineering runs or a process performance qualification ( PPQ ), and we could go from paper to a commercial process in one step .
However , we know we need that manufacturing experience to leverage quality reliability and get closer to quality predictability . An example is how robust characterisation reports in a programme set the stage for successful product quality .
In addition , we look at the strength of the critical process parameters ( CPPs ) and key performance indicators ( KPIs ) for establishing a process . While there are plenty of regulations and guidance documents available on these topics , it comes down to the critical thinking that goes into a program to reliably manufacturing a product at a given quality level by a capable team – or in other words – quality of performance and reacting appropriately for improvement .
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