John O’NeillModeratorJune 23, 2022 at 10:22 pmPost count: 56
My company was recently informed by our vendor for our product bottles that the manufacturer had changed resins 3 years ago and did not notify anyone. And it’s not as simple as replacing resin A with resin B. They were replacing it with different kinds of resin. We are fully aware that we need to cover our bases on this issue. We were given the Part numbers along with lot numbers of bottles that are in question. So we have personnel export data for these lots. We are pretty much at a loss as to how we can resolve this or where to even start. Does anyone have suggestions on how or where to start? Manufacturer has currently stated that they do not have any background studies on resins used.John O’NeillModeratorJuly 6, 2022 at 7:07 amPost count: 56
It appears that since these changes occurred as long as 3 years ago, you may have some of the “new resin lots” on stability as part of your annual commercial lot program. This assumes that you trace the new resins into these lots. A conference with your internal regulatory colleagues may result in their filing some Change-related documents where your product is registered, and the official regulatory bodies of those areas will direct you to the appropriate course of action. A worst-case scenario would be product recalls; the best case is modified protocols and potentially modified test methods. A quick check with your Extractables and Leachables Group would be a good idea and if surplus samples are available within any lots on stability containing these substitute resins, using some of these to do an accelerated study could provide a higher confidence level as you wait for your long-term results. An iso-conversion program such as ASAP may be a good investment to get some data and a prognosis quickly. Thinking holistically, building strong relations and communications with your suppliers to emphasize the importance of knowing about any changes well in advance can help prevent future occurrances, but I’ll admit that trying to push your quality concerns upstream into the considerations of your supplier’s suppliers is a difficult endeavor. As your situation develops, let us benefit from your experience so the rest of us can address this type of risk.
John O’Neill StabilityHub Editor
- You must be logged in to reply to this topic.