"The following is an edited excerpt taken from The Windshire Group’s webcast Quality in the Laboratory:…
The following answer to the question “What if I have a component that is a critical piece of the process, but there is only one supplier that can provide it, and they recently failed their supplier audit?” is taken from The Windshire Group’s webcast, “Pharmaceutical Supplier Auditing: How to Achieve Consistent Results Expert Panel Discussion.”
Dr. James Blackwell: Well, I would say it’s not a fun situation to be in. I think this is an example of where you need to understand what it takes to address that criticality (please see my bulletpoints below) and work with them on it. It sounds like a situation where if you really need them to supply that product, they may need additional support from your company. You need to consider that because as the question states, you don’t have a backup supplier. And so you either stop manufacturing, or you need to help them fix their problems. The situation may be complex, i.e., legal issues to deal with and so forth. But you know there’s no easy answer to a situation like this one, for sure.
- Supplier auditing is a critical activity for the quality of your product
- It should be used prior to selecting critical suppliers
- It is a valuable tool throughout the relationship lifecycle
- Anticipate mismatches between quality systems between your organization and your supplier’s, and proactively manage this
- Example- large company using small company with less mature quality system
- Sometimes the supplier will need support to address findings
- Are critical findings able to be readily addressed? Will they need additional support?
Dr. James Blackwell, Ph.D. M.B.A. is the Founder and Principal Consultant of The Windshire Group. The Windshire Group offers “Comprehensive CMC and Management Consulting”sm to the regulated life science industry. For further information, please contact firstname.lastname@example.org; (+1) 844.686.5750
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- To read the complete free transcript click here