What is the stability situation?

My QA VP forwarded a vendor’s two-paragraph memo regarding modification of the cap liner for bottles used with our suspension product that’s been on the market for several years. After contacting the vendor directly, I learned that they modified the primary layer (contacting product) of the 4-layer liner by changing the anti-oxidant to better prevent degradation and peeling - something we had not had any problems with over our 3 year product shelf-life.

What the memo didn’t indicate was that the change was actually implemented two years ago. “We apologize for any inconvenience your company may incur as a result of this change,” the memo said. Are they kidding? We have a quality agreement in place requiring advanced notice of such changes, but we slipped through a crack in their systems. Fortunately, we can trace the specific inventory in which the new liner was used.

Meanwhile, on our annual stability program we have 12 months of data from our 2021 batch packaged using the revised liner and 6 months of data from our 2022 batch. The protocol calls for reconstituting and holding sample for 60 days at each stability interval, so we have some data to support potential leaching. No changes were detectable in any of the data we have, but at just 1/3 of the shelf-life, that seems weak, not to mention we no longer have the quantity of package-specific data we claimed in our registration.

What strategies do you recommend supporting continued use of this liner to prevent disruption of supply and especially to avoid a recall?

How should this be resolved?

Initiate a product recall or put a stability plan in place to satisfy the regulatory authorities. What are your thoughts for a best-case outcome?

We Want to Hear Your Thoughts!