Vexed by Vendors
All Situation Room examples are constructed and not descriptions of actual events.
Published on: October 12, 2022
Walter Routh
Share This Article with the Stability Community!
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!
September 30, 2023
Many of us have been there; you have some initial stability data that would save a lot of time and money if you didn't have to support it with further studies, but sometimes circumstances cast regulatory shadows that bring about difficult decisions. What to do?
August 23, 2023
When a study will be significantly impacted by delayed enrollment of an annual batch none of the options are appealing. We look forward to your discussion of the preferred action.
August 1, 2023
Facing a change in packaging volume for our prescription digestive aid capsules, we're weighing three options to maintain our stability commitment, which alternates between 100ct and 500ct bottles each year, despite the fact that 100ct bottles will not be filled in 2023.
Share your questions and experiences
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
