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Hello Participant,
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
