Annual batch selection based on packaging site only

[njrazorback]

#26014

Bumping this up in the forum. I’d like to hear from others if they are required to have annual lots from every manufacturing and packaging site combination or if they are able to choose from one mfg site one year and the other mfg site the next. What would need to be in the filing to allow this?

[John O’Neill]

#26027

Not currently in possession of a Commercial Product on Stability, but my experience has been that batches from all sites/packaging are required unless negotiated otherwise through regulatory bodies. This might be achieved with some rigorous scientific justification such as comparability study data.

[Author]

Posts