Ho-Hum. Just Another OOS.

Our stage 3 injectable allergy medication has demonstrated stability for 2 years at 5°C in amber glass but we are switching to clear glass due to poor customer experience—amber vials look scary and it’s hard to aim the syringe needle. The product is actually photo-stable and clear glass shows no change through 6 months at 5°C, but at 25°C we had a failure at 2 months and now apparently again at 3 months. The label states that the product can be left out at room temperature for a full 2 weeks, even though historically it was stable through 3-months at accelerated.

As the R&D project lead on this packaging change, I insist these accelerated results are expected and consistent with historic data, but upper management is nervous that we’ve messed with a “good thing”. They see an industry trend of companies running to the hills at the first sign of unexpected accelerated failures, even when a logical approach can be taken to continue with the new packaging and current labeling. How can I assure management that the product, as labeled, continues to be supported by our data—past and present?

Consider reading the July article by Pearl Pereira-Nambiar entitled “When a Batch Fails at Accelerated Stability” and show upper management this quote from the article: “So a failed accelerated interval does not automatically mean the product is unstable. But it does mean your justification has to now work harder where you need to connect the dots. A better justification explains why the accelerated failure is or is not relevant to the proposed storage condition, packaging and shelf-life.”