Veterinary product in Human medicine production facility

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear All

  1. Is it possible to manufacture both the Human and veterinary aseptic product in the same facility,same machine? or do we
    need separate facility?

  2. Could we manufacture different strength of same product( e.g “A” product-2 gm, 1 gm 500 mg) one after the other?
    for example-Its an aseptic production. we would like to fill 1gm, 500 mg strength of product A, in the same day one after the another without cleaning, as its the same API we need like to adjust only the fill volume. the other documets-e.g sterilization , cleaning would be same.
    Is there any regulatory bar.

Thanks

2

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.

Regards

3

if we go for TGA and MHRA approval, do these regulatory bodies expect seperate facility for the purpose?

4

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.