What is the stability situation?
The 3-month interval samples at long-term conditions were sent to the lab for testing 3 weeks ago. We sent enough material to complete all tests twice, except dissolution—but there was plenty to meet S3 testing requirements. Unfortunately, due to lab errors and bad luck, the dissolution testing went through S2 and they discovered they do not have enough to proceed to S3—Apparently other tests were also invalidated and repeated. They need an additional 12 tablets.
The shelf life of this product is only 12-months, so I’m concerned that a 3-week difference between these new S3 tablets could skew that data. We don’t require exception documentation automatically when testing proceeds to S3, so the fact that these additional tablets will be almost 4-months old won’t be evident in the data and reports.
Any thoughts on how best to document these additional samples? What are your processes in place to avoid such a situation?
How should this be resolved?
If you had a reserve sample process (additional material pulled and held by you or the lab in case of problems like this) then sending additional material would not have to come from the chamber but could have been stored in the same way as the other lab samples. Does anyone else have a reserve sample process in place? Please tell us about it.
We Want to Hear Your Thoughts!