SUPPLY CHAIN MANAGEMENT
Given that the individual customer is the ultimate arbiter of quality for any project , how can a CDMO implement it as a general policy ? I think this really depends on the CDMO – a proven track record makes all the difference on this topic . As a CDMO , we strive to make sure there is alignment with our customer up front on the approach we are going to take so we know how we are going to react in advance . No one wants to write a playbook in the middle of the play . So , with advanced planning and mutual understanding , we strive for predictable and aligned outcomes .
What is the importance of corrective and protective actions ( CAPA )? It is important , because we talk about it in one word , CAPA , but it is really about two outcomes – correction and prevention . The first pitfall is overfocusing on correction at the expense of prevention . And the second pitfall is applying this to a manual process and expecting it to behave in a binary way . Manual processes are complex , and we have to embrace the fact that they are manual before we try to apply CAPA appropriately , in order to minimise frustration . engage in strong planning up front through a production schedule that can significantly help to improve ‘ right first time .
We also have key ‘ board ’ meetings at our sites , including a ‘ CAPA board ’ and a ‘ change control board ’ to ensure proper stakeholders are aware , engaged and providing input for successful outcomes . Lastly , we have periodic quality meetings , like our quality management reviews and quality councils . And of course , quality topics are shared in quarterly business reviews as well . These are just a few highlights . ●
Can the costs of poor quality in the pharma industry for customers and patients be measured ? Yes , but there are a lot of models on how to measure the actual and / or potential costs of poor quality . All of them include assumptions . So , aligning on what those models assume is an important factor in interpreting the results of that model . |
How does Thermo Fisher implement its quality communication plans ? From a high level , there are several avenues of quality communication . At Thermo Fisher , we are firmly embedded in our tier huddle board management process at all our sites . We also spend a good amount of time on quality-related topics and |
J j |
Steven Falcone
SENIOR DIRECTOR , COMPLIANCE & EXTERNAL ENGAGEMENT , PHARMA SERVICES
THERMO FISHER SCIENTIFIC
Steven . falcone @ thermofisher . com www . patheon . com
|
NOV / DEC 2023 SPECCHEMONLINE . COM
51