Expert: Michael Anisfeld - 1/17/2008

Question
Hello Michael,
A three years ago, we received approval for a product and the first three production batches were placed on the LT stability. However, due to certain circumstances, the product was never launched. Now we have decided to launch the product. Nothing has changed in terms of equipment or process. Do we need to place three new batches on the stability program or the existing batches on the program would suffice for our stability commitment?

Answer
If absolutely nothing, and I do mean nothing, has changed, then there is no need to repeat the long term stability studies.

This means that the raw materials are the same grade and sourced from the same source (factory of manufacture), all equipment to be used now was used in initial stability batches, and the batch manufacturing records have not changed with respect to sequence of materials addition, amounts of materials, and operating parameters.