Our vial supplier just notified us they are ending production of the Type I glass vials we’ve been purchasing from them for over 10 years for our generic injectable steroid medications. At least stoppers aren’t a problem (yet!). We are located in and distribute primarily in the US, but since we make low-margin generics we have not invested in qualifying alternative suppliers and don’t even have one identified—although there certainly are numerous options. We will be able to stock up on enough vials for another 18 months of production before implementing a change.
Packaging engineers and product QA folk claim that stability data is not required prior to making this change and insist that any Type I glass vial of equivalent dimensions will suffice with the change only requiring a CBE 30. Our regulatory group is tending toward that opinion, as well. To top it off, it turns out management’s decision against investing in alternate supplier qualifications hinged on this strategy, so they love it.
I’m pressing the change team for at least 6 months of stability data on three batches in the new vials to support 24-month shelf-lives, along with the normal stability commitment to continue the studies to expiry. Given the number of products, we’re talking about a few million dollars for stability. Then there’s timing—after identifying and commissioning a new supplier we’ll barely have a year to pull stability data together and file the change.
Am I right for insisting on stability data prior to submitting the change?
Are they right that any certified “Type I” glass vial is acceptable as long as it meets our incoming quality specs?
What are your thoughts?