Aseptic Processing technology, Guidelines, Standards, Cleaning methodologis-Limits are same for both Human and Veterinary Products.
There are no short cuts when it comes to line clearences and cleaning procedures.
Seperate Facility? Do we need it or not?
Its with in the regulatory guidance you usually approach.
Honestly speaking they must be sperate.
You cannot have intermixing of lables for similar products. The dosages and potencies varie eventhough the manufacturing standards are exactly similar.
If a manufactiring process switched from A mg to B mg for the same API that has to be filled or formulated-Filtered and filled all you need to know how good your environmental controls are after filling first A mg. You refered about powder filling.
In such a case you need to know all the incomming components are FIT FOR THE PURPOSE and also Environment FIT FOR FILLING after a product was filled.
We talk about Sterility Assurance Level. It comes with robust environmental procedures.
if we go for TGA and MHRA approval, do these regulatory bodies expect seperate facility for the purpose?
I do not know about that because we never manufactured both in the same facility. The descision will be left to Regulatory agencies to grant that facility permission. I cannot comment.