Q: What is FDA’s perspective on contracts or quality agreements with sister sites — sites owned or operated by the same parent company — that supply the primary manufacturer with materials or components?
When using a sister site as a supplier, is it necessary to have documents in place that define specific roles and responsibilities? Or do we just need to be able to access the supplier data and monitor performance?
A: Interestingly, FDA has straddled both sides of the fence on this issue.
When FDA sees a problem with material coming from a sister site, it likely will insist that you put into place written quality agreements and expectations about those materials. But if FDA doesn’t see problems coming from your sister site, it likely will believe that whatever you’re doing is effective and doesn’t require any additional agreements
“It’s very important to have a written understanding regarding exactly who’s going to do what and when.”
From my perspective as a former FDA investigator and current industry auditor, I believe it’s very important to have a written understanding with any site — especially a sister site — regarding exactly who’s going to do what and when.
I’ve seen far too many instances where a sister site forgets (or neglects) to monitor material specifications because it figures the other site will perform a quality inspection at a certain point.
Especially among sites who presumably are all “on the same team”, there’s too much potential for misunderstandings and far too much potential for critical things to fall through the cracks.
So I believe quality agreements should be worked out between sister sites, and that they are very valuable. Ideally, agreements between sister sites should be easier to develop than ones with a supplier not related to you at all. Such agreements will give you a much better process and stronger level of control. And generally, FDA is going to believe that, too.
But does FDA always require such agreements? No. When there’s a problem, though, the Agency will invariably require them for corrective action.
Answered by Martin Browning, President and Co-Founder of EduQuest, who served 22 years at the U.S. FDA as an expert field investigator, co-wrote 21 CFR Part 11, and contributed to the development of 21 CFR Part 820 — the Quality System Regulation. Martin is the lead instructor of EduQuest’s Managing and Auditing Supplier Quality training class.