Recently I’ve noticed that the discussion of separate facilities is getting deeper, especially on Beta-Lactam group.
i. One may suggest that a group of Beta-Lactam can be produced under one roof.
ii. While another person have suggested that each group such as Penicillin, Ceph & Penems need to have separate buildings.
iii. I’ve also received some suggestion that penems can be produced in either Penicillin or Ceph facilities.
From my point of view, either Penicillin, Cephalosporin, or Penem, they should be produced in their own isolated facilities. But again it is not a simple statement. We need to look on overall issue such as utilities, personnel, material flow, labs, risk assessment, etc…
To all my GMP colleague, may I know what is the acceptable practices in your country?
Thanks in advance.