We would like to implement a policy that allows selection of annual batches based on packaging sites only, and not based on manufacturing site. In other words, out of two approve manufacturing sites and two approved packaging sites we would only place two stability batches on each year–one from each packaging site, regardless of the manufacture site. This does not contradict any filed stability commitments. The proposal is based on documented evidence of equivalency between the manufacturing sites and also with a former CDER guideline specifically stating that selection of annual batches must be minimally based on packaging site. I cannot find any current guidelines speaking to that, however. Also, we are hoping to implement this with biologics, as well, and I do not know if this used to be in the CBER guideline. Has anyone implemented (or rejected) such a policy or is anyone aware of a guideline speaking specifically to this topic?
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