Home › Forums › General Discussion › The Situation Room: Primary Packaging Pressure Pickle › Reply To: The Situation Room: Primary Packaging Pressure Pickle
Totally agree with the lack of quality inspection/approval of vendor as a first line argument to get internal attention, but would also be on the hunt in the literature for 483’s and Warning Letters associated with package development shortcomings. While this packaging “change” was overt, it’s not uncommon for package-related changes to creep into stability studies because a supplier to your supplier made changes that weren’t noted by them, or perhaps they did note it and your primary supplier didn’t pass the news on to you. The other under-the-radar challenge is when package descriptions come to the Stabilitarian in generalities without getting into details such as polymer composition or changes to a cap liner. We may think A=B because they have the same generic description. We need to be diligent in demanding a detailed package description and comparing it with the packaging materials utilized by other stability study batches in the same project. We may unwittingly be comparing apples to oranges within the same study. I’ve seen it happen.
